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- 2026-07-22 03:12:20
- Opinion
- "CHE, limitations of steroids…attention is now focused on 'Anzupgo'"
- by Son, Hyung Min Jun 26, 2026 09:45am
- In the treatment of chronic hand eczema (CHE), treatment strategies are shifting toward to match individual patient conditions, moving away from the repeated topical corticosteroid (TCS) use.With the introduction of LEO Pharma's 'Anzupgo (delgocitinib),' a non-steroidal topical pan-Janus kinase (JAK) inhibitor, clinical experts evaluate that a viable therapeutic option for use before advancing to systemic therapy is now available.Professor Margitta Worm, Department of Dermatology and Allergy, Charité – Universitätsmedizin Berlin, GermanyDuring a meeting with DailyPharm, Professor Margitta Worm emphasized the critical importance of "timely intervention" in treating chronic hand eczema.Professor Worm explained that rather than cycling through ineffective topical corticosteroid treatments, shifting the therapeutic strategy at the right clinical window based on the patient's disease severity is essential to mitigating long-term disease progression and functional decline.Chronic hand eczema (CHE) is a chronic inflammatory skin condition characterized by itching and pain. It causes a heavy socioeconomic burden, including absenteeism, reduced productivity, impaired hand function, occupational limitations, and diminished quality of life (QoL). Because the hands are the most actively utilized body parts in both daily routines and professional activities, persistent symptoms disrupt work performance, interpersonal relationships, and general daily living. The disease burden is particularly pronounced among professions that require repetitive hand use, such as healthcare professionals, hairdressers, chefs, and manufacturing workers, often making career retention difficult. In real-world clinical practice, we often see identical TCS regimens repeated or to delay transitions to systemic therapy, even for patients who fail to respond adequately to initial topical corticosteroids. This therapeutic delays is cited as a major driver of chronic disease persistence and relapses. Consequently, "timely treatment," modifying the therapeutic strategy at the optimal juncture, is emerging as a new core management principle.The topical JAK inhibitor Anzupgo is leading the shift in the therapeutic landscape. Anzupgo cream was developed for use across various clinical subtypes of chronic hand eczema by targeting the JAK-STAT signaling pathway to modulate multiple inflammatory cytokines, rather than suppressing a single pathway.In the global Phase 3 DELTA 1 and DELTA 2 clinical trials, one in two patients achieved a 75% or greater improvement in symptoms (HECSI-75) after 16 weeks of treatment. The long-term efficacy and safety profiles were further validated in the DELTA 3 open-label extension study, which followed patients for up to 52 weeks. Furthermore, the investigator-initiated trial (IIT) known as the 'Del-Bi study' demonstrated upregulation of key structural proteins responsible for maintaining the skin barrier. This has drawn significant industry attention to the drug's potential for restoring the skin barrier beyond simple symptomatic relief.Professor Worm emphasized, "A substantial number of chronic hand eczema patients miss the optimal therapeutic window by repeatedly relying on topical corticosteroids when they actually require stepped-up therapy. If initial efficacy is inadequate, clinicians should pivot the therapeutic strategy promptly rather than waiting, thereby preventing long-term disease exacerbation and deterioration of the patient's quality of life."Q.Delayed treatment remain the primary issue in chronic hand eczema management. Delayed diagnosis and treatment are currently recognized as critical clinical challenges in CHE. A Danish cohort study involving approximately 4,000 patients found that a significant proportion of patients with chronic hand eczema experience prolonged delays before initiating systemic therapy.Notably, approximately 44% of the total patients required more than 8 years to reach their first systemic treatment line. While clinical timelines vary by patient severity, these findings suggest that at least 50% of moderate-to-severe CHE patients are essentially candidates for immediate transition to stepped-up therapy.During these periods of delayed treatment, patients typically undergo multiple cycles of repeated topical corticosteroid (TCS) applications. While TCS remains the foundational first-line therapy for chronic hand eczema, there is a distinct clinical tendency to cycle through identical or similar TCS regimens repeatedly without transitioning to higher-tier therapies at the appropriate time aligned with disease severity.Q. Given the disease burden of CHE, what is the clinical significance of having this new therapeutic option available?Chronic hand eczema severely impacts a patient's life. It not only disturbs individual daily routines but also compromises overall workplace operational capabilities, while severe pain and pruritus significantly degrade health-related quality of life (HRQoL). If adequate therapy is not initiated promptly, the condition inevitably worsens over time. Crucially, the affected patient group is not confined to the elderly but includes a significant proportion of the young and working-age population. In these cases, the negative impact reverberates across individual labor capacity, career longevity, and the broader macroeconomic landscape, translating into a societal economic burden driven by absenteeism and lost productivity. Chronic hand eczema absolutely demands appropriate therapeutic intervention, and fortunately, dedicated treatments are now available. With the advent of novel therapeutics driven by innovative R&D, it is vital to actively leverage these safer, more effective clinical options for patients. Existing topical corticosteroids carry risks of adverse events that can paradoxically worsen the patient's skin condition over the long term, particularly by further degrading the critical skin barrier function. In this regard, a novel alternative was a highly anticipated clinical unmet need. Q. What changes have been brought to the CHE treatment landscape since the introduction of Anzupgo cream?The emergence of a novel topical agent capable of controlling the disease while reducing dependence on topical corticosteroids (TCS) represents a significant paradigm shift in the treatment landscape of chronic hand eczema.Previously, the standard clinical pathway was to transition directly to systemic therapies if symptoms remained uncontrolled despite TCS use. Now, clinicians have an additional, highly effective topical option to use before that escalation step. Consequently, this provides a new clinical window to pursue a safer, more effective treatment before deploying systemic regimens, thereby curbing the overreliance on topical corticosteroids.Q. What are the reasons for Anzupgo cream to be applicable across diverse clinical subtypes, and what are its key clinical advantages?A clinical strength of this agent is its excellent local tolerability. Both in clinical trials and real-world experience, adverse events related to local skin irritation were rarely reported, demonstrating a highly favorable local tolerability profile. This encourages high patient compliance and supports long-term adherence without treatment resistance or aversion. Another critical differentiator is its rapid onset of action and sustained long-term efficacy. Pruritus, a hallmark symptom that severely compromises patient quality of life, demonstrates marked improvement as early as Day 1 of application. Statistically significant reductions in pain are also observed within days of initiation, specifically by Day 3 in clinical trials. Clinical data show that this rapid initial efficacy and disease control are overall sustained in long-term studies extending up to 1 year (approximately 52 weeks). This swift symptomatic relief, combined with durable efficacy, directly drives high patient satisfaction and encourages treatment persistence. While some patients respond well and experience delayed recurrence even after temporary discontinuation, others experience a relatively rapid return of symptoms post-cessation. For the latter group who experience swift recurrence, long-term maintenance therapy can be evaluated based on the 52-week long-term safety and efficacy data established in the DELTA 3 study.Q. Could you elaborate on the background, key findings, and clinical implications of the 'Del-Bi study,' an investigator-initiated trial (IIT)?The Del-Bi study was specifically designed to evaluate whether Anzupgo cream triggers downstream physiological changes within the skin barrier beyond superficial symptom suppression. The trial enrolled active, working-age patients with chronic hand eczema, with a mean age of approximately 43.Following a 12-week treatment regimen, skin tissue biopsies revealed a statistically significant upregulation of key structural proteins essential for maintaining the skin barrier compared with baseline. These findings suggest that Anzupgo cream goes beyond simply resolving visible lesions; it actively contributes to the structural repair and restoration of the damaged skin barrier. This can potentially mitigate the penetration of external irritants and lower the risk of subsequent inflammatory flares, providing meaningful clinical evidence for stable, long-term disease management. Q. What are the key advantages of Anzupgo cream that clinicians can anticipate in real-world practice?Even with topical formulations, there are often clinical apprehensions regarding systemic drug absorption leading to systemic exposure issues. However, even in the 52-week long-term extension study, Anzupgo cream did not exhibit clinically significant or elevated systemic concentrations in blood samples.Consequently, there is no need for routine blood monitoring or laboratory testing, which is a significant advantage for both patients and healthcare providers. From a patient convenience standpoint, this agent alleviates the burden of unnecessary diagnostic testing, while also positively impacting healthcare economics by reducing ancillary medical expenditures. Furthermore, in terms of clinical efficacy, Anzupgo cream demonstrated consistent therapeutic outcomes across the various chronic hand eczema subtypes. This uniform efficacy represents a major practical advantage in real-world settings, allowing clinicians to use the treatment broadly without having to strictly categorize patients into rigid clinical subgroups. Overall, the successful development and availability of such an innovative therapeutic agent is highly encouraging,
- Policy
- "100-day health insurance listing period for rare disease drugs"
- by Lee, Jeong-Hwan Jun 26, 2026 09:45am
- The Minister of Health and Welfare, Jung Eun Kyeong, is briefing on the administrative transformation of medical fees.The Ministry of Health and Welfare (MOHW) will substantially shorten the health insurance listing period for rare disease therapeutics and will establish a "Korea-centric primary care model" where local clinics assume full responsibility for patient prevention and management.On June 25, the MOHW convened the 12th Health Insurance Policy Review Committee to deliberate on and discuss the ▲Implementation of the expedited listing pilot program for rare disease therapeutics and ▲Revised plan for the community primary care innovation pilot program.With this decision, therapeutic access for patients with severe and rare diseases will be significantly improved, and the primary care sector anticipates a shift in the reimbursement framework from being disease treatment-centric to "management-centric."'100-Day Fast-Track Listing' for rare disease novel drugs...underperforming drugs face price cuts or delisting after 5 yearsInstead of drastically shortening the health insurance listing period for rare disease therapeutics, the MOHW will implement a "conditional reimbursement" system that rigorously evaluates real-world clinical performance within 5 years post-listing to adjust drug prices. Commonly referred to as the "List-First, Evaluate-Later" policy, this mechanism grants reimbursement proactively, but revokes reimbursement if clinical efficacy or health insurance efficiency cannot be verified during post-marketing assessments.The intent behind this administrative action is to enhance patient access through expedited listings while ensuring the fiscal efficiency of the national health insurance fund through rigorous post-marketing management.The core of the policy involves applying a mandatory five-year post-marketing evaluation cycle and differentially adjusting drug prices, ranging from maintaining the price to enforcing full out-of-pocket patient payment, depending on therapeutic performance outcomes.According to the detailed plan disclosed, rare disease therapeutics subject to expedited listing will be managed under a "conditional reimbursement" form, undergoing post-marketing evaluation and reimbursement adjustments within five years.Years 1 to 3 represent the data collection period. Led by the Health Insurance Review and Assessment Service (HIRA), a domestic real-world data (RWD) registry will be established to generate real-world evidence (RWE).Year 4 begins the post-marketing evaluation period. The evaluation will focus primarily on HIRA's RWE, along with a comprehensive review of domestic and international clinical trials and real-world evidence materials submitted by the pharmaceutical company. Economic evaluations will also accompany the process for drugs amenable to such analysis or upon the manufacturer's request.Year 5 is when the reimbursement adjustment takes place. Reimbursement will be adjusted based on the clinical outcome evaluation or economic evaluation results, followed by negotiations with the National Health Insurance Service (NHIS).Notably, the criteria for reimbursement adjustments based on post-marketing evaluations are classified into four tiers and applied very strictly.The condition for maintaining the drug price applies only to Grade 1 cases, where definitive superiority is proven across key clinical endpoints, resulting in recognition of "substantial or significant improvement."A 10% price reduction is applied to Grade 2 cases in which only "general improvement" is confirmed, such as significant improvement in surrogate endpoints, a reduction in common adverse events, or significant improvement in convenience, or when the size of the benefit cannot be quantified due to statistical limitations.A 20% price reduction, or a similar adjustment, applies to Grade 3 cases that receive a "no improvement (non-inferiority)" determination due to clinical utility comparable to alternative therapies; these will be adjusted to the weighted-average price of alternative therapies or reduced by 20%.Transitioning to full out-of-pocket payment applies to Grade 4 cases, which are determined to have "inferior" clinical utility due to lower clinical efficacy or a higher risk of adverse events compared to alternative therapies; these will be excluded from reimbursement status and shifted entirely to full patient self-pay.A refund procedure will also be established for any additional financial expenditures incurred after the conditional reimbursement window (from listing up to 5 years) to account for potential evaluation or negotiation delays.Pilot program to launch in the second half…clinical evidence expected to be accumulated by 2027The "Expedited Listing Pilot Program for Rare Disease Therapeutics," which applies this post-marketing evaluation framework, will be rapidly advanced starting in the second half of this year. While the specific budget has not yet been finalized as target candidate drugs are currently being selected, the projected financial impact per therapeutic asset will be submitted for the Committee's review in the near future.The detailed timeline for plans includes a public notice of target candidate drugs for the pilot program between July and August of this year.In September, applications will be reviewed for eligibility to select the final target drugs, and starting in October, legal agreements will be established with participating medical institutions to officially drive the expedited listing process forward.From 2027 to 2032, clinical evidence data will be accumulated over the next five years, followed by the execution of post-marketing evaluations and reimbursement adjustment procedures.The government intends to establish policy grounds based on the operational status and performance analysis of this first pilot phase and, if necessary, launch a second pilot program in sequence. A "utility-centered" operation of the NHI fund, which significantly broadens access to novel drugs directly linked to patient survival while decisively offloading therapies lacking proven clinical efficacy, is anticipated to face a critical testing ground.Total 1.6% increase in clinic-level medical fees for 2027..."Concentrating compensation on essential healthcare"The 2027 conversion factor (medical fee) growth rate for clinic-level providers, which had previously fallen through during negotiations with the National Health Insurance Service in May, has been finalized at 1.6%.However, the increase will not be applied uniformly. The MOHW decided to reflect only 0.9% of the total 1.6% directly into the conversion factor adjustment (setting the unit price per point at KRW 96.5), while allocating the remaining 0.7% to increase the Relative Value Units (RVUs) for essential healthcare and undervalued medical acts, such as basic consultation fees. The detailed plan for this relative value adjustment will be finalized through a subsequent Health Committee session.An official from the MOHW explained, "By linking the conversion factor with relative value modifications, we can enhance policy acceptance at the clinical site and ensure appropriate compensation is funneled directly into critically needed areas of essential medicine."Clinic-centered Korea-centric primary care physician...introduction of 'Integrated Medical Fee System'The "Community Primary Care Innovation Pilot Program," which enables patients with multiple comorbidities to receive structured health management services at local clinics, will enter full implementation in September.The defining characteristic of this pilot program is the introduction of an "Integrated Medical Fee System." Deviating from the traditional "Fee-for-Service" model, where consultations, laboratory tests, and procedures are billed individually, a comprehensive, integrated bundled fee will now be applied based on Hierarchical Condition Category (HCC) risk adjustment scores, accounting for the patient's age, sex, and underlying comorbidities.Korea-centric Primary Care: A multidisciplinary team of physicians, nurses, physical therapists, and others delivers comprehensive health management services (prevention, education, counseling, and care coordination).Optional compensation will also follow. Medical institutions can choose between the integrated medical fee system and the existing fee-for-service model based on their operational capacity. Clinics selecting the integrated medical fee path will be granted additional financial incentives, such as premium fee markups and performance rewards. Furthermore, even if the hospital reimbursement model changes, the patient's out-of-pocket copayment structure will remain unchanged from the legacy system."Anticipating a Structural Transformation in Primary Care"The MOHW expects this pilot program to transform the current fragmented clinical culture, which focuses heavily on episodic disease treatment, into an approach centered on prevention and longitudinal management. The ministry plans to call for institutional applications between July and August, with selected clinics officially deploying services starting in September.Meanwhile, during the session, the Health Committee finalized the 2027 clinic-level National Health Insurance reimbursement cost growth rate, agreeing to tie a portion of the financial allocation to enhanced compensation for essential medical sectors.A ministry official stated, "Beyond simple disease management, we will solidify the institutional foundations to ensure citizens can access high-quality primary care directly within their local communities. We will gather extensive feedback from the field to guide stable policy establishment."
- Policy
- Expanded Olumiant coverage still falls short of patient expectations
- by Jung, Heung-Jun Jun 26, 2026 09:45am
- Although Lilly Korea’s Olumiant (baricitinib) has achieved broader reimbursement coverage for severe alopecia areata, the criteria remain a point of contention among patients, who argue that the current guidelines require more reasonable adjustments.The medical community also warns that many patients who have long awaited reimbursement coverage may still face limited access to the high reimbursement standards.According to industry sources on June 24, numerous patient complaints were submitted during the public comment period on Olumiant’s proposed reimbursement criteria for severe alopecia areata, which concluded on June 22.Under the proposed reimbursement criteria, patients must satisfy two requirements to qualify for insurance coverage. First, they must have received at least three months of treatment with conventional therapies such as systemic corticosteroids or cyclosporine without achieving at least a 30% reduction in disease severity, as measured by the Severity of Alopecia Tool (SALT), or they must have been unable to continue treatment because of adverse effects.To qualify as having severe disease, patients must either have a SALT score of 50 or higher, or have both eyebrows and eyelashes completely absent or clearly interrupted with a SALT score between 20 and less than 50.To maintain reimbursement, patients must achieve a SALT score of 20 or lower at the initial assessment conducted at Week 36.Thereafter, reimbursement eligibility will be reassessed every six months to confirm maintenance of the initial treatment response, with reimbursement limited to a maximum of 2 years.Patients argue that because severe alopecia areata is a chronic autoimmune disease with a high likelihood of recurrence, limiting reimbursement to two years is insufficient.One patient who submitted an opinion during the public consultation stated, “Rather than imposing a uniform two-year limit, reimbursement should be extended based on periodic evaluations of SALT scores and patients' clinical status.”Previously non-reimbursed patients face 2 reimbursement criteria barriersThe proposed policy also includes transitional provisions for patients who have been receiving Olumiant at their own expense. However, these patients must demonstrate that they met the current reimbursement criteria when treatment was initiated. To do so, they must provide evidence such as prior treatment history and photographs documenting disease severity.The issue is that patients must satisfy both requirements: ▲prior treatment history and ▲ disease severity. Patients who began Olumiant based solely on severity without prior treatment, or those who underwent prior treatment but lack adequate documentation of disease severity at that time, would not qualify for reimbursement.Critics argue that satisfying both requirements is excessively burdensome for the patients because patients with autoimmune diseases often experience interruptions in treatment over several years or receive care at multiple medical institutions.Another patient who submitted comments stated, “The policy is essentially telling patients to stop treatment, wait until their condition worsens again, and then receive reimbursement for retreatment,” and criticized the proposal as being out of touch with reality.The medical community also expressed concern that the proposed reimbursement criteria could substantially restrict patient access.Professor Chang-Hun Huh of the Department of Dermatology at Seoul National University Bundang Hospital said, “Patients with severe forms of alopecia like alopecia totalis and alopecia universalis were in such desperate need as they have exhausted all known treatment options. It is disheartening for us as medical professionals because the current reimbursement criteria may actually limit the benefits for patients that have long awaited reimbursmenet, especially to those who have already been receiving treatment.
- Company
- New patent registrations surge 41% this year
- by Kim, Jin-Gu Jun 26, 2026 09:45am
- A total of 142 products were newly registered in the Ministry of Food and Drug Safety’s (MFDS) Green List during the first half of this year, representing a 41% increase from the same period last year.The trend differed sharply between Korean subsidiaries of multinational pharmaceutical companies and Korean companies. The number of newly listed products from the Korean subsidiaries of multinational pharmaceutical companies surged 53%, from 72 to 110, while domestic pharmaceutical companies posted only a modest 10% increase, from 29 to 32.Among multinational companies, Eli Lilly Korea stood out with patent listings related to its obesity treatment Mounjaro (tirzepatide), while Chong Kun Dang drew attention among domestic companies with patent listings for diabetes combination therapies.New patent listings reach 142 in 1H… multinationals account for 77% of registrationsAccording to the MFDS on June 24, a total of 88 new patents were added to Korea’s Green List during the first half of this year, protecting 142 pharmaceutical products.In 1H last year, 101 products (66 patents) were newly listed. Measured by the number of listed products, this represents a 41% year-over-year increase.Patent registrations by Korean subsidiaries of multinational pharmaceutical companies were particularly prominent. Of the 142 newly listed products, 77%, so 120 products, belonged to multinational companies.The number of companies registering at least one patent increased from 18 to 24. The number of products listed by these companies rose from 72 to 110, a 53% increase, while the number of patents increased from 47 to 74, up 57%.In contrast, domestic pharmaceutical companies showed slower activity. The number of domestic companies registering at least one patent fell from 14 in 1H last year to 8 this year. The number of listed products increased only slightly, from 29 to 32 (10%), while the number of patents declined 26%, from 19 to 14.Lilly focuses on Mounjaro patents…Total reaches 48 since 2023Among multinational companies, Eli Lilly Korea was the most active patent filer, adding 22 products to the Green List during 1H this year alone.Most were related to the obesity therapy Mounjaro. These included 6 Mounjaro QuickPen Inj products (1 patent) and 12 Mounjaro vial products (2 patents).Lilly has continued to register Mounjaro-related patents since 2023.The company registered 12 products in 2023, 6 in 2024, 12 in 2025, and 18 in 1H this year, bringing the cumulative number of patent-protected Mounjaro products to 48.In addition, Daiichi Sankyo Korea newly listed 10 products related to ‘Datroway Inj’ and ‘Vanflyta Tab (6 patents).’ Astellas Pharma Korea listed 9 products related to ’Vyloy Inj’, while AstraZeneca Korea listed 8 products for ‘Lokelma Suspension Powder .’ Sanofi-Aventis Korea followed with 7 products, while AbbVie Korea, Medison Pharma Korea, Roche Korea and Takeda Korea each registered 6.Chong Kun Dang registers 14 diabetes combination products…followed by Celltrion, then SamohAmong domestic pharmaceutical companies, Chong Kun Dang and Celltrion’s listings stood out.Chong Kun Dang registered 14 new products on the Green List, which is the highest among Korean companies. The company filed 6 patents on ‘Duviempol XR Tab (lobeglitazone/empagliflozin/metformin),’ 4 patents on ‘Empamax M XR Tab (empagliflozin/metformin),’ 2 patents on ‘Empamax Tab (empagliflozin),’ and 2 patents on ‘Duviempa Tab (lobeglitazone/empagliflozin).’ All are diabetes combination therapies.Among them, Duviempol XR Tab and Duviempa Tabtab are combination therapies based on Chong Kun Dang’s in-house developed drug ‘Duvie ,’ which contains the active ingredient lobeglitazone.Empamax and Empamax M XR are improved versions of Boehringer Ingelheim’s Jardiance, whose substance patent expired in October last year. Chong Kun Dang applied co-crystal technology to empagliflozin to prevent discoloration seen with existing products and used a coating technology to address the compound’s susceptibility to moisture.Celltrion registered 1 patent each for its Remicade(infliximab) biosimilar ‘Remsima Pen’ and ‘Remsima Prefilled Syringe,’ as well as 4 patents related to the antihypertensive combination ‘Edardipine Tab (azilsartan/amlodipine).’Samo Pharmaceutical newly listed 3 dosage strengths of ‘Voxzogo (vosoritide),’ a treatment for pediatric achondroplasia. The patent holder is U.S.-based BioMarin, while Samo Pharmaceutical is listed as the Korean patent registrant. Samo introduced Voxzogo to the Korean market through its specialty medicines business unit and obtained domestic approval in December 2024.In addition, Hanmi Pharmaceutical filed 1 patent each for ‘Mirabek SR Tab’ and ‘Soranib.’ Sam-a Sam-A Pharm filed patents for 2 dosage strengths of ‘CITUS Chewable Tab,’ and Korea Pharma filed 2 patents related to ‘Accrufer Cap.’ Hyundai Pharm filed 1 patent for ‘Winlevi Cream.’
- Company
- ‘Yescarta demonstrates potential for long-term survival’
- by Son, Hyung Min Jun 25, 2026 09:04am
- The role of CAR-T therapy is expanding in the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).With long-term survival data for Yescarta being secured in patients who relapse or become refractory within 12 months of first-line treatment, treatment strategies in the second-line setting are also beginning to evolve.On June 24, Gilead Sciences Korea held a press conference in Seoul to mark the domestic launch of its CAR-T therapy ‘Yescarta (axicabtagene ciloleucel),’ highlighting the current treatment landscape and the therapy's clinical value in relapsed/refractory DLBCL.Professor Dok Hyun Yoon of the Division of Oncology at Asan Medical Center emphasized that substantial unmet needs remain for patients with relapsed or refractory DLBCL.Professor Dok Hyun Yoon of the Division of Oncology at Asan Medical CenterProfessor Yoon said, “DLBCL is the most common subtype of non-Hodgkin lymphoma, and some patients experience relapse or become refractory even after first-line treatment. In particular, patients who relapse within one year have a very poor prognosis, making the choice of treatment in the second-line setting significantly important for long-term outcomes.”DLBCL is one of the most aggressive forms of lymphoma. First-line treatment typically consists of R-CHOP-based chemoimmunotherapy (rituximab, cyclophosphamide, vincristine, and prednisone). While many patients can achieve complete remission with this regimen, approximately 30–40% eventually experience relapse or refractory disease.The challenge arises after relapse. In Korea, salvage chemotherapy followed by autologous stem cell transplantation remains the primary treatment strategy. However, treatment outcomes remain limited in real-world practice.“Response rates to salvage chemotherapy are generally low in relapsed or refractory patients, and only a limited number of patients proceed to autologous stem cell transplantation. Given the limitations of conventional therapies, it is important to implement advanced treatment options at the appropriate time to improve long-term survival.”Value of second-line CAR-T therapy confirmed in clinical trialsProfessor Seok Jin Kim, Division of Hematology-Oncology at Samsung Medical CenterProfessor Seok Jin Kim, Division of Hematology-Oncology at Samsung Medical Center, reviewed results from the pivotal ZUMA-7 study and emphasized the importance of the timing of CAR-T therapy.Yescarta is a CAR-T therapy manufactured using a patient’s own T cells, which are genetically engineered to recognize CD19 expressed on the surface of cancer cells.In Korea, Yescarta is approved for second-line treatment of adult patients with DLBCL that relapses within 12 months after first-line chemoimmunotherapy or is refractory to treatment, and for the treatment of relapsed or refractory DLBCL and primary mediastinal B-cell lymphoma (PMBCL) after at least two prior lines of systemic therapy.Notably, it is currently the only CAR-T therapy approved in Korea as a second-line treatment.The Phase III ZUMA-7 study compared Yescarta with standard-of-care treatment, including salvage chemotherapy and stem cell transplantation, in patients with large B-cell lymphoma who relapsed within 12 months of first-line therapy or were refractory to treatment.Results showed that Yescarta significantly improved event-free survival (EFS) compared with standard treatment and reduced the risk of relapse or death by 60%. In a four-year follow-up analysis, Yescarta reduced the risk of death by 27%, while the median overall survival (OS) had not yet been reached.“Even though a substantial number of patients in the standard-care arm later received CAR-T therapy or bispecific antibody treatments, the survival benefit of Yescarta was maintained. This demonstrates the importance of using CAR-T therapy at the appropriate stage rather than repeatedly administering multiple lines of therapy after relapse.”He added, “Patients who relapse within one year or are refractory from the outset face an extremely high risk of death from the disease. That is why CAR-T should be considered from the second-line setting.”Kim further noted, “More than half of these patients survived beyond four years, even though long-term survival would have been difficult to expect in the past in this population. The treatment goal in relapsed/refractory DLBCL is evolving from simple disease control to achieving long-term survival.”Gap remains between global standards and Korean clinical practiceExperts also highlighted the shift toward earlier use of CAR-T therapy.The current National Comprehensive Cancer Network (NCCN) guidelines recommend CAR-T therapy as a major second-line treatment option for patients with DLBCL who relapse within 12 months of first-line therapy or are refractory to treatment.In the past, patients with relapsed disease were first treated with salvage chemotherapy and autologous stem cell transplantation, with CAR-T therapy considered only later in the treatment sequence. However, treatment paradigms are increasingly shifting toward earlier use of CAR-T therapy in high-risk patients.Professor Kim said, “CAR-T therapy has already become a standard second-line treatment option in many countries. Korea also needs to establish an environment that allows patients to receive this therapy at the appropriate time.”Yescarta is currently reimbursed in 30 countries worldwide, and the cumulative number of treated patients has surpassed 28,700. Gilead Sciences Korea stated that it plans to continue discussions to broaden treatment access for patients in Korea.
- Policy
- MOHW acknowledge need for 'CSO Association' establishment
- by Lee, Jeong-Hwan Jun 25, 2026 09:04am
- The Ministry of Health and Welfare (MOHW)As the President Lee Jae Myung administration designates the eradicating illegal Contract Sales Organizations (CSOs) and illicit pharmaceutical rebates as a core national normalization agenda, the Ministry of Health and Welfare (MOHW) is preparing to review the temporary CSO Association's authorization as an official legal association.Following the legalization of the mandatory CSO registration system, the MOHW acknowledges the need for an official communication channel with the CSO industry. This channel is deemed essential for addressing the proliferation of illegal CSOs and curbing expedient, unhealthy distribution and sales practices, such as illicit rebates.The CSO Association, whose previous two applications for incorporation were rejected, is expected to undergo an official regulatory review process once it submits the required documentation, including updated business plans, to the MOHW.On June 24, an official from the MOHW’s Division of Pharmaceutical Policy stated, "With an increasing number of pressing issues related to CSO advancement and rebate eradication, such as conducting investigative surveys on CSO practices and refining relevant systems, we recognize the need to establish an association to serve as an official communication channel with the CSO sector."The MOHW had previously rejected the temporary CSO Association's applications for incorporation during the document screening phase. The rationale for the rejections was reportedly a lack of industry representativeness and insufficient detail in the association's business plans to warrant official legal-entity status. Consequently, the organization has operated as a temporary entity for approximately 4 years, focusing on enhancing transparency in CSO operations.The regulatory momentum shifted significantly after the MOHW finalized its drug-pricing reform plan, which includes reductions in generic drug prices. This policy shift amplified the urgent need to eliminate CSO-mediated rebates as a critical follow-up measure.As the government continues to monitor unhealthy distribution, sales, and prescribing practices in which certain pharmaceutical companies or medical institutions exploit CSOs, blocking illegal CSOs entirely has become crucial. This aligns with the government's broader goals for the domestic pharmaceutical industry, which is to accelerate global market expansion and shift the industrial ecosystem toward blockbuster novel drug development.Currently, the MOHW, in collaboration with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), is developing a robust regulatory framework to ensure a transparent drug distribution environment following CSO registration. This initiative will kick off with a comprehensive status survey on CSO consignment and re-consignment practices.The establishment of the CSO Association is garnering significant attention because it will provide the MOHW with a direct, centralized stakeholder to consult on advancing CSO regulatory policies.The approval process for establishing a legal association involves the CSO Association submitting an application to the MOHW. Once the MOHW reviews and passes the documentation, the proposal is referred to the 'Non-Profit Corporation Review Committee' for final approval.A MOHW official explained, "An official channel for communicating with the CSO industry is necessary, which is why we agree on the need for the association's establishment." And added, "Once they supplement the previously missing documentation and reapply, we will review it in accordance with relevant regulations."Accordingly, the incorporation process is expected to accelerate once the temporary CSO Association meticulously prepares and submits the necessary paperwork to the MOHW.Meanwhile, the association plans to elect a new president at its upcoming board meeting this summer to expedite the administrative procedures required for official approval.
- Company
- Insomnia drug Dayvigo approved in Korea
- by Son, Hyung Min Jun 25, 2026 09:04am
- Eisai Korea announced on the 24th that its insomnia treatment Dayvigo (lemborexant) received approval from the Ministry of Food and Drug Safety (MFDS) on June 23 for the treatment of adult patients aged 18 years and older who have difficulty initiating or maintaining sleep.Dayvigo is a dual orexin receptor antagonist (DORA) class drug that works by reversibly binding to orexin receptors OX1R and OX2R, thereby suppressing excessive wakefulness signals mediated by orexin, a neurotransmitter involved in maintaining wakefulness.Unlike conventional benzodiazepine or non-benzodiazepine (GABA class) sleep medications, which broadly suppress neural activity throughout the brain, Dayvigo promotes sleep by regulating wakefulness, allowing for a more natural sleep process.The recommended dose is 5 mg taken once daily immediately before bedtime. Depending on patient response and tolerability, the dose may be increased to a maximum of 10 mg.The approval was based on the global Phase III SUNRISE 1 and SUNRISE 2 studies.SUNRISE 1 enrolled 1,006 insomnia patients aged 55 years and older and compared Dayvigo with extended-release zolpidem and placebo.After one month of treatment, latency to persistent sleep (LPS) decreased by 19.5 minutes and 21.5 minutes in the Dayvigo 5 mg and 10 mg groups, respectively, compared with reductions of 7.9 minutes in the placebo group and 7.5 minutes in the extended-release zolpidem group.Sleep efficiency (SE) increased by 12.9% and 14.1%, respectively, while wake after sleep onset (WASO) decreased by 43.9 minutes and 46.4 minutes.In particular, wake after sleep onset during the second half of the night (WASO2H) decreased by 27.2 minutes and 28.8 minutes in the Dayvigo 5 mg and 10 mg groups, respectively, compared with a reduction of 21.4 minutes in the extended-release zolpidem group.Improvements were also confirmed in the SUNRISE 2 study, which evaluated Dayvigo’s long-term efficacy.In the study, which enrolled 949 adult insomnia patients aged 18 years and older, subjective sleep onset latency (sSOL) at 6 months decreased by 21.8 minutes and 28.2 minutes in the Dayvigo 5 mg and 10 mg groups, respectively, compared with an 11.4-minute reduction in the placebo group.Subjective sleep efficiency (sSE) increased by 14.2% and 14.3%, while subjective wake after sleep onset (sWASO) decreased by 46.8 minutes and 42.0 minutes, respectively. Response rates for both sleep initiation and sleep maintenance were higher than those observed with placebo, and the benefits were observed and maintained from the first week of treatment through 6 months.In terms of safety, somnolence was the most frequently reported adverse event in both studies. However, the incidence of serious adverse events was low. No rebound insomnia or withdrawal symptoms were observed, and no new safety concerns emerged during 6 months of long-term treatment.Hong-byung Koh, CEO of Eisai Korea, said, “Despite the significant impact insomnia has on patients’ daily lives and quality of life, unmet needs remain in treatment. We hope that the approval of Dayvigo will expand patient access to a new treatment option capable of addressing not only sleep onset insomnia but also sleep maintenance insomnia.”
- InterView
- [Reporter's View] Connecting the dots btwn minister replacement rumors
- by Lee, Jeong-Hwan Jun 25, 2026 09:04am
- Rumors of a replacement of the Minister of Health and Welfare, Jung Eun Kyeong, have surfaced. The apparent reasons cited are the delayed execution of President Lee Jae Myung’s national agenda and insufficient policy performance.However, it remains difficult to discern whether these replacement rumors are based on an objective evaluation of the ministry's operational and policy performance, or if they are a political maneuver reflecting the administration's mid-term impatience.Notably, as rumors of the minister's replacement circulated, the controversial proposal to expand National Health Insurance (NHI) coverage for hair loss therapeutics has emerged rapidly. This raises critical questions about the rationality and validity of the current administration’s policy-making approach.Healthcare and welfare administration is a highly specialized domain that must simultaneously safeguard public health and life expectancy while ensuring the fiscal sustainability of the national health insurance fund financed by public premiums. Therefore, Minister Jung’s performance cannot be judged solely by the timeline demanded by the Presidential Office.The core of the criticism of Minister Jung’s "insufficient performance" centers on her perceived lack of momentum in aggressively advancing the Lee Jae Myung administration's core campaign promises.However, from the ministry’s perspective, rushing mid- to long-term projects that require massive financial resources without meticulous simulations risks intense criticism for ignoring societal priorities.Given that the NHI fund is projected to shift into deficit, it would be unreasonable for Minister Jung to allocate hundreds of billions of won annually to a non-life-threatening condition like alopecia.Before holding the minister accountable, there must first be objective verification that the "execution speed" demanded by the Presidential Office falls within a rational range that today's society and administrative systems can actually absorb.As replacement opinions are rising, it is highly problematic that the Ministry of Health and Welfare (MOHW) suddenly accelerated the hair loss reimbursement policy by announcing a public opinion collection process. The administrative ministry cannot escape criticism that it is making a sharp policy shift under pressure from the presidential term, rather than conducting a rational and valid review grounded in fiscal soundness and the public's right to health and life.This explains external assessments that the sudden replacement of Sue-ran Lee, the First Vice Minister of Welfare, just one year into her appointment, has put intense pressure on Minister Jung and Hyung Hoon Lee, the Second Vice Minister of Health, to deliver policy results immediately.The national health insurance fund is not unlimited. Its resources are finite. When setting reimbursement priorities within limited budgets, the primary criteria must strictly be 'disease severity' and 'fatality.' Even if pledged during the presidential campaign, decisions that undermine the foundational pillars of insurance prioritization should not be made lightly. Such steps inevitably pit patient advocacy groups against each other, driving social chaos, friction, and conflict.Isn't the root cause of this confusion and social friction the malfunctioning or total absence of mutual consultation and coordination channels between the Presidential Office and the MOHW?While the politically driven motives of the Presidential Office and the risk-management administration of the ministry, which oversees fiscal health and public safety, may naturally clash on specific issues, a head-on collision must be averted through robust, frequent communication between the ruling administration and the ministry.A decision-making process in which the Presidential Office determines and the ministry blindly designs and enforces administrative implementation is not a rational policy-making process for South Korea. Unilateral mandates from the executive branch, coupled with implicit pressure to replace a minister who fails to comply rather than cross-organizational communication, is a system that the informed Korean public will not accept.'People's government' recognized by the public can be realized only when a permanent·continuous communication system is established or restored to horizontally reconcile the administration's political agenda with the ministry's administrative expertise, ensuring that health insurance reimbursement policies are designed·implemented based on rational evidence and meticulous coordination.
- Policy
- Celltrion’s Omlyclo takes aim at Xolair’s with pen formulation
- by Jung, Heung-Jun Jun 25, 2026 09:03am
- Celltrion is pursuing differentiation with its Xolair biosimilar Omlyclo (omalizumab) through reimbursement listing of a pen formulation that is not available with the original product.With Novartis Korea withdrawing the vial formulation of Xolair and shifting its focus to the prefilled syringe (PFS) formulation, Celltrion is expected to chase Xolair using its proprietary pen device.According to industry sources on June 23, Omlyclo Pen Inj (0.15 g/1 mL), an allergy and asthma treatment approved in Korea in December last year, is scheduled to be added to the reimbursement list next month.The original product, Xolair, generates annual sales of approximately KRW 20 billion in Korea and more than KRW 5 trillion globally. Celltrion entered the market in September 2024 with its biosimilar Omlyclo and has since been competing with Xolair.Until now, Celltrion has sought to penetrate the market by offering a lower price than the original product. While Xolair PFS 0.15 g is priced at KRW 216,755, Omlyclo PFS of the same strength is priced roughly 20% lower, at KRW 173,404,In the case of the 0.3 g PFS formulation, Xolair is priced at KRW 360,356, compared with KRW 252,200 for Omlyclo, a difference of approximately KRW 110,000.Xolair’s market in Korea is centered on its PFS formulation. The original vial formulation of Xolair is undergoing marketing authorization withdrawal procedures and is expected to be removed from the reimbursement list in January next year.Following the reimbursement listing of Omlyclo PFS 0.3 g in April this year, Celltrion will add Omlyclo Pen Injection 0.15 g to the reimbursement list beginning in July. The reimbursed price of the pen formulation will be the same as that of the corresponding PFS formulation, at KRW 173,404.Unlike the prefilled syringe, the pen formulation does not expose the needle, and therefore has the advantage of being less intimidating due to the concealed needle, while also offering greater ease of administration.Celltrion is therefore expected to accelerate its market expansion efforts in the second half of the year by leveraging both lower pricing and a new formulation as key differentiators.Competition is also expected to intensify outside Korea. Onlyclo has already been launched across several European markets, including Germany, Spain, Denmark, and the Netherlands, where it continues to expand market share. The company is also preparing its U.S. launch in the second half of this year.
- InterView
- ‘Imfinzi used as perioperative gastric cancer treatment’
- by Son, Hyung Min Jun 24, 2026 09:19am
- “Surgical outcomes in gastric cancer have steadily improved, but recurrence remains the biggest challenge in patients with stage 2 and 3 disease. It is time to adopt a therapeutic strategy that addresses micrometastasis even before surgery.”Professor Hyoung-il Kim of the Division of Gastrointestinal Surgery and Professor Minkyu Jung of Medical Oncology at Severance Hospital recently explained so in an interview with DailyPharm, noting that perioperative therapy based on ‘Imfinzi (durvalumab)’ could become a new option for managing recurrence in gastric cancer.(From the left) Professor Minkyu Jung of Medical Oncology and Professor Hyoung-il Kim of the Division of Gastrointestinal Surgery at Severance HospitalGastric cancer is one of the most common cancers in Korea. Although overall survival is on the rise with the increased early detection through the National Cancer Screening Program, in patients with advanced-stage disease, recurrence remains the biggest factor determining long-term prognosis.In particular, patients with resectable stage 2 or 3 gastric cancer still face a considerable risk of recurrence even after curative surgery and postoperative adjuvant chemotherapy. In real-world clinical practice, approximately 20% to 30% of stage 2 patients and more than half of stage 3 patients are known to experience recurrence.In many cases, cure is often difficult once recurrence is confirmed. For this reason, how well recurrence can be reduced during the initial treatment phase is considered a key determinant of treatment success.Experts point to micrometastasis as a major cause of such recurrence, as it is difficult to detect with conventional imaging tests. Micrometastasis refers to minimal residual disease (MRD), in which tumor cells have already spread systemically through the bloodstream or lymphatic system at the time of diagnosis but remain undetectable with existing imaging tests. In other words, cancer cells too small to be detected by preoperative CT or laparoscopic examination may already have spread via the blood or lymphatic vessels, eventually causing the cancer to recur after the operation.Until now, the standard treatment for resectable gastric cancer has been surgery followed by postoperative chemotherapy. Although postoperative chemotherapy has helped reduce recurrence risk, concerns have continued that it has limitations in sufficiently controlling micrometastasis in patients at high risk of recurrence.Against this backdrop, interest is rising in strategies that begin treatment before surgery, when tumor burden is relatively low and immune function is preserved to suppress micrometastasis early. In particular, the rising potential of perioperative immunotherapy has influenced the gastric cancer treatment paradigm.In March this year, AstraZeneca’s immunotherapy ‘Imfinzi (durvalumab)’ obtained an indication as perioperative therapy for patients with resectable gastric cancer and gastroesophageal junction adenocarcinoma. The treatment strategy involves administering Imfinzi in combination with perioperative FLOT chemotherapy (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) in patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma, followed by maintenance treatment with Imfinzi monotherapy.In the global Phase III MATTERHORN trial, which served as the basis for approval, perioperative therapy with Imfinzi reduced the risk of disease progression, recurrence or death by 29% compared with existing treatment. In the overall survival (OS) analysis, it also reduced the risk of death by 22%, demonstrating a survival benefit. It also showed significantly improved results versus the control group across key endpoints, including event-free survival (EFS) and pathological complete response (pCR).Surgery remains the cornerstone of curative treatment for gastric cancer. However, both in Asia and globally, there is growing recognition that surgery alone is insufficient to achieve cure in many gastric cancer patients. The MATTERHORN trial showed that administering immunotherapy plus FLOT before surgery, followed by curative resection and additional treatment, can meaningfully improve long-term treatment outcomes.The two professors said, “The goal of treating resectable gastric cancer is not simply to complete surgery successfully, but to reduce recurrence and improve long-term survival. Imfinzi perioperative therapy is meaningful in that it enables early management of micrometastasis, and we expect its use in real-world clinical practice to expand based on appropriate patient selection and multidisciplinary care.”They added, “In particular, for stage 2 and 3 patients at high risk of recurrence, the clinical value of a new treatment option is significant. Ultimately, reimbursement needs to be set so that patients can timely recieve treatment opportunities.”Q. For high-risk patients, strategies to enhance the completeness of surgery appear to be crucial. From this perspective, what are the current gaps in gastric cancer treatment strategies that require improvement?"[Professor Hyoung-il Kim]: The core goal of gastric cancer surgery is to precisely remove cancer tissue and lymph nodes while minimizing damage to normal tissue. In recent years, advances in laparoscopy, fluorescence-guided technology, and robotic surgery have continued to improve surgical precision.However, no matter how many advances are made in terms of surgical techniques, there are areas that cannot be addressed by surgery alone. The most significant recent shift in addressing these limitations is the emergence of perioperative therapy based on immunotherapy. While chemotherapy was historically aimed at delaying recurrence, the current focus has evolved toward reducing the recurrence rate itself and increasing the likelihood of long-term survival.Q. In the MATTERHORN trial, Imfinzi perioperative therapy significantly improved the primary endpoint of event-free survival (EFS). How do you think these results could change patient prognosis in practice?Professor Minkyu Jung of Medical Oncology at Severance Hospital[Professor Minkyu Jung]: Various studies of immunotherapy-based perioperative therapy have been conducted in gastric cancer, but some did not produce results as strong as expected.By contrast, the global Phase III MATTERHORN trial was encouraging, as it is the first study to demonstrate clinical benefit of immunotherapy-based perioperative therapy in patients with resectable gastric cancer.The combination of Imfinzi and FLOT significantly improved EFS by reducing the risk of disease progression, recurrence, or death from any cause by 29%, and also showed a meaningful improvement in OS.I also consider it important that pCR was approximately 2.7 times higher than in the control group. It is highly significant that the preoperative administration of the Imfinzi-FLOT combination has led to a pCR rate of approximately 19.2% by effectively managing invisible micrometastases and minimal residual disease before surgery.As patients who achieve pCR are generally considered to have the best treatment response, a favorable long-term prognosis can also be expected. Another point worthy of attention is that a relatively consistent treatment effect was observed, regardless of PD-L1 expression status.Q. A multidisciplinary strategy seems very important in perioperative therapy. How are treatment decisions made at Severance Hospital?Professor Hyoung-il Kim of the Division of Gastrointestinal Surgery at Severance Hospital[Professor Hyoung-il Kim]: With the introduction of perioperative therapy, changes are needed across the entire treatment process. For perioperative therapy to be applied effectively, it is important to accurately determine which patients are most likely to benefit from this treatment.To do this, a system must be in place to identify patients who need preoperative immunotherapy at the right time, refer them from surgery to medical oncology, and ensure that preoperative treatment and surgery proceed in an integrated manner. In this process, multidisciplinary care plays a very important role, as specialists from surgery, medical oncology, radiology, pathology, and other fields need to jointly evaluate the patient’s stage and recurrence risk to determine the optimal treatment sequence.From the patient’s perspective, it may feel unfamiliar to come to the hospital for surgery and then be told to receive immunotherapy before surgery. Therefore, the process of building trust with the patient by clearly explaining the need for treatment and its expected benefits through multidisciplinary collaboration is also important for successful treatment.Q. When applying Imfinzi perioperative therapy in practice, it seems important to determine which patients should be prioritized. Beyond simple resectability, what factors are comprehensively assessed when deciding whether and how to treat patients?[Professor Minkyu Jung]: In Korea and Japan, gastric cancer is often detected relatively early, so preoperative treatment does not need to be applied to all patients. Representative high-risk groups include patients whose tumors are shown on imaging to have deeply invaded the gastric wall or patients suspected of having lymph node metastasis.These patients have a higher risk of recurrence and may be more likely to benefit from preoperative treatment. In addition, the need for preoperative treatment may be greater in gastroesophageal junction cancer, as surgery can be complex and complete resection may be difficult due to anatomical characteristics.Q. What is your view on the need for reimbursement for Imfinzi perioperative therapy?[Professor Hyoung-il Kim]: Since this perioperative approach has confirmed its meaningful clinical benefits in a Phase III study, it is well worth reviewing its reimbursement coverage. In particular, because nearly half of patients with stage 3 gastric cancer experience recurrence even after surgery, rapid reimbursement coverage is needed so that high-risk patients can be identified first and given timely treatment opportunities.[Professor Minkyu Jung]: At present, there are no reimbursed treatment options that can be used as perioperative therapy in patients with resectable gastric cancer. Especially in high-risk patient groups, even when a treatment has demonstrated clinical value, treatment choices may be limited due to financial burden. Therefore, I believe institutional support that reflects clinical need is necessary so that patients do not miss treatment opportunities due to economic burden.Q. What efforts do you think are needed to improve Korea’s gastric cancer treatment outcomes?[Professor Minkyu Jung]: Korea has a well-established system for early detection of gastric cancer through the national screening program, but blind spots still exist. Patients who have not undergone regular screening and visit the hospital only after symptoms appear are often diagnosed at stage 3 or 4. I think finding these high-risk groups more effectively will be an important task going forward. In addition, as new treatment options such as immunotherapies and targeted therapies continue to emerge, research is also needed to develop personalized treatment strategies tailored to each patient’s characteristics.[Professor Hyoung-il Kim]: In gastric cancer, treatment goals differ depending on the timing of detection and disease stage. For patients detected early, maintaining quality of life as much as possible after treatment is important. For patients detected at an advanced stage, reducing recurrence and improving survival are the key challenges. Surgical techniques continue to evolve through robotic surgery, fluorescence-guided surgery, and other advances, but recently, the importance of drug therapy has grown in areas that were difficult to address with surgery alone. Should effective drug therapies continue to advance, we may be able to bring patients previously deemed unsuitable for surgery into the range of surgical treatment.
