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- 2026-05-08 14:15:58
- Policy
- Re-evaluation of the upper limit amt, scheduled for August
- by Lee, Tak-Sun Jul 31, 2023 05:27am
- The final result of the re-evaluation of the upper limit amount standard requirement will be presented as an agenda for the Pharmaceutical Reimbursement Evaluation Committee to be held on August 3. It is expected that negotiations with NHIS will proceed in earnest after the submission of the committee. The results of the re-evaluation of the adequacy of this year's benefits are expected to be presented in September. According to HIRA and the industry on the 28th, the committee meeting on the 3rd of next month will review the final result of the re-evaluation of the upper limit amount standard. This is the final review following the first review in May. HIRA notified pharmaceutical companies of the results after the first review by the review committee in May. After that, the final result will go to the committee on the 3rd of next month after the appeal. This is about two months behind the original plan to reflect drug price adjustment through re-evaluation in July. This is because data submissions were rushed all at once in February, and more than 1,000 objections came out after the first evaluation. After this committee is over, the NHIS is expected to hold negotiations with pharmaceutical companies regarding supply for the month of August. It is expected that the re-evaluation results will be reported to the health policy review committee in August, and the drug price adjustment plan will be reflected in the reimbursement list on September 1. The re-evaluation of the upper limit amount is being carried out by maintaining or lowering the upper limit amount depending on whether the drug has met its own BA test and DMF listing criteria for already-listed drugs. The upper limit is maintained if both BA and DMF requirements are met, and if one is met, the price is reduced to 85% of the adjusted standard price, and if both are not met, the price is reduced to 72.25%. Currently, the first evaluation of 14,000 items is underway, and the second round of about 5,000 drugs will begin in earnest after submitting data in July. The re-evaluation of the adequacy of wages this year is expected to be somewhat delayed due to the re-evaluation of the maximum amount. The original plan was to submit the re-evaluation results to the Drug Evaluation Committee in August, but it is likely to be presented in September at the earliest. This year, the target item for re-evaluation of benefit adequacy is peptic ulcer medicine Rebamipide, a drug for the circulatory system Limaprost Alfadex, an antipyretic, analgesic, anti-inflammatory drug Loxoprofen Sodium, a drug for the digestive system Levosulpiride, a drug for allergy Epinastine Hydrochloride, an ophthalmic hyaluronic acid eye drop. Among them, hyaluronic acid eye drops are the largest with a market size of 231.5 billion won (3-year average billing amount). Next, the pharmaceutical industry is paying attention to the results of the re-evaluation of the adequacy of reimbursement for these drugs.
- Company
- Erleada can be prescribed at tertiary hospitals in KOR
- by Eo, Yun-Ho Jul 28, 2023 05:30am
- The new prostate cancer drug Erleada has landed in general hospitals in Korea. According to industry sources, Janssen Korea’s metastatic hormone-sensitive prostate cancer (mHSPC) treatment Erleada (apalutamide) has passed the drug committee (DC) review at the Big 5 tertiary hospitals in Korea, - Samsung Medical Center, Seoul National University Hospital, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, and Sinchon Severance Hospital – and its prescription code has been already inserted into 60 medical institutions nationwide. The drug has seemingly quickly settled in the prescription market after it was listed for reimbursement in April. Erleada is an androgen receptor-targeted agent (ARTA) that is in the same class and a follow-up to ‘Zytiga (abiraterone)’ and ‘Xtandi (enzalutamide).’ The drug demonstrated its safety and efficacy in the Phase III TITAN trial in 1,052 patients with mHSPC. Despite the fact that about 40% of the patients assigned to the placebo group continued treatment with Erleada during the study, the risk of death in the Erleada group was 35% lower than that of the placebo group. Overall survival (OS) at 48 months was 65% in the Erleada group and 52% in the placebo group. Also, when excluding the effect of patients who switched medication from the placebo group to Erleada, the risk of death in the Erleada group was 48% lower than that of the placebo group. Meanwhile, according to the National Cancer Registration Statistics Program, the number of patients diagnosed with prostate cancer in 2020 was 16,815, ranking third in men following lung cancer (19,657) and stomach cancer in (17,869). The number surpassed that of colorectal cancer (16,485). In addition, among the 5 major male cancers (lung cancer, stomach cancer, prostate cancer, colorectal cancer, and liver cancer), only the rate of prostate cancer has been increasing, and at an annual average rate of over 5%.
- Policy
- Janssen’s MM drug Tecvayli Inj is approved in KOR
- by Lee, Hye-Kyung Jul 28, 2023 05:30am
- On the 26th, the Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) approved ‘Tecvayli Inj (teclistamab),’ a rare disease drug used to treat multiple myeloma. Tecvayli is used in adult patients with relapsed and refractory multiple myeloma who have received at least three previous lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Tecvayli is a bispecific antibody that binds to the B-cell maturation antigen (BCMA) on myeloma cells, and CD3 on T-cells. Tecvayli binds to BCMA and CD3 and induces myeloma cell death via activation of T cells. BCMA is a cell surface protein that is selectively induced during plasma cell differentiation. It is an ideal target for plasma cell cancer (multiple myeloma). The MFDS stressed that it will continue being committed to the rapid provision of safe and effective treatment for the Korean people based on its expertise in regulatory science.
- InterView
- ‘Leclaza can occupy 50% of mkt if used as combination'
- by Jung, Sae-Im Jul 28, 2023 05:30am
- Yuhan Corp’s Leclaza (lazertinib) was the first homegrown new drug to be approved as a first-line treatment for EGFR mutation-positive non-small-cell lung cancer. The industry’s eyes are now on how the drug will fare in the global market. Will Leclaza be able to rise as a new contender to AstraZeneca’s ‘Tagrisso (osimertinib)’ that is dominating the global market? The key lies in the clinical results of 'MARIPOSA', which is being conducted by Janssen. The Phase III MARIPOSA study directly targets the current first-line standard-of-care Tagrisso with Janssen’s ‘Rybrevant (amivantamab)’ and Leclaza combination. If the Rybrevant+Leclaza combination demonstrates a progression-free survival (PFS) superior to that of Tagrisso, this could bring major change to the current treatment environment. The interim results of MARIPOSA phase 3 are expected to be presented at the European Society for Oncology (ESMO) Congress 2023 which will be held in October. “If the MARIPOSA trial ends a success, third-generation options for the first-line treatment of EGFR-mutation-positive NSCLC will increase to 3 (Tagrisso, Rybrevant+Leclaza, Leclaza). I think it's very significant that two-thirds of the options include the use of Leclaza." Professor Byoung-Chul Cho (Medical Oncology, Yonsei Cancer Center) and Professor Ki Hyeong Lee (Hemato-Oncology, Chungbuk National University Hospital) Professor Byoung-Chul Cho (Medical Oncology, Yonsei Cancer Center) and Professor Ki Hyeong Lee (Hemato-Oncology, Chungbuk National University Hospital) met with the reporter at the LASER Symposium that was held on the 22nd for medical oncologists and relayed their anticipation on Leclaza’s potential as a global new drug. According to clinicaltrials.gov, a registry and results database of clinical studies, the MARIPOSA study divided 1,074 patients around the world into three treatment arms. Treatment Arm A will receive Rybrevant+Leclaza and Arm B and C will each receive Tagrisso and Leclaza as monotherapy. The study seeks to demonstrate that the Rybrevant+Leclaza combination therapy is superior to Tagrisso. Tagrisso has settled as the global standard of care with progression-free survival (PFS) of 19 months when used in the first-line. Therefore, achieving a statistically significant superiority will be very difficult. Conversely, if the clinical trial produces good results, it would also be that much of a game-changer. Professor Cho said, “The standard for statistical significance was set quite high in the clinical trial that compared Rybrevant+Leclaza and Tagrisso. I have high expectations for the study because I believe the cancer treatment paradigm will shift from the use of monotherapy to combination therapies. After the results of the MARIPOS clinical trial are presented, the company will sequentially start its approval process in the US. If approved, two of the three options in the field will include the use of Leclaza, and simple arithmetic can tell us that the drug can occupy up to 70% of the market share. "This will have a significant impact on prescriptions," he predicted. Although it is not the main point of the trial, the study may also serve as an opportunity to recognize the effect of Leclaza once again as it also evaluates Leclaza and Tagrisso as monotherapy in one trial. Leclaza demonstrated a long progression-free survival of 20.6 months in the global Phase III LASER301 trial that was presented last year. Although this is longer than what Tagrisso had achieved in its Phase III trial, the two are not directly comparable due to the different patient groups enrolled in each study. The MARIPOSA study includes Tagrisso and Leclaza monotherapy arms, which allows for the efficacy between the two to be examined. Professor Lee said, “I want to know if the results from the LASER301 clinical trial and its subgroup analysis will show consistently in the MARIPOSA study. If we see positive results in that trial, it would be an opportunity for HCPs to recognize the efficacy of Leclaza. If successful, I believe Leclaza would be able to take over 50% of the market.” Tagrisso is also seeking to expand its indication through the FLAURA2 trial, which examined Tagrisso’s use in combination with chemotherapy. The combination obtained statistically significant top-line results recently and will announce the results in the second half of the year. However, the professors believe the FLAURA2 trial will not cause a major change in the current treatment landscape. Professor Cho held the 1st generation gefitinib+chemotherapy combination in the past as an example. The combination had shown a significant improvement in overall survival (OS), and a related paper was published in the Journal of Clinical Oncology (JCO) published by the American Society of Clinical Oncology (ASCO) and also listed in international guidelines. However, no one has been actually prescribing this combination on-site. Cho added, “Those who have experience dealing with a lot of EGFR mutations are confident that they can achieve the same results with monotherapy without adding chemotherapy. Adding chemotherapy is effective with immunotherapy, but the situation is different in EGFR-mutation-positive NSCLC, as we are already achieving high response rates with targeted therapies alone. The MARIPOSA trial is at another level compared with the FLAURA2 trial.” Professor Lee said, “Chemotherapy not only brings side effects, but I'm just personally not sure if it works. I think chemotherapy will disappear from the market in the future. With the advent of targeted therapy, there is no reason for us to go back and use chemotherapy, so it is difficult to understand why we should consider using it again even as a combination.”
- Policy
- Maintenance of grounds for original drug price
- by Kim, Jung-Ju Jul 27, 2023 05:40am
- The government will establish a legal basis so that the insurance price of the original drug can be reduced ex officio when a generic of an original drug whose patent has expired is listed on the drug reimbursement list. It is interpreted that they are trying to respond to pharmaceutical companies by preparing a clear basis for the ex officio adjustment drug price lawsuits that arise every time. The Ministry of Health and Welfare made a legislative announcement on the 26th and announced the implementation date of the 'Partial Amendment Decree of the Rules on the Standards of National Health Insurance Medical Care Benefit' with this content. The government is lowering the price of the original drug through an ex officio adjustment when the patent of the original drug expires and generic drugs are to receive insurance benefits to compete with it. However, as patent disputes with generic development companies heated up, there were many cases where lawsuits for suspension of execution, which neutralized the government's ex officio coordination, were filed together, so there was a need to prepare a legal basis. In response, the government decided to clearly establish the basis for 'whether a drug is eligible for medical care benefit and the disposition of ex officio adjustment of the upper limit amount' determined and announced by the Minister of Health and Welfare under the Health Insurance Act. This will have the effect of strengthening the legal basis for pharmaceutical companies to respond head-on when they file a drug price lawsuit against the Ministry of Health and Welfare in the future. This amendment is a follow-up measure to reorganize detailed regulations as Article 41-3 (5) of the Health Insurance Act was prepared. The government plans to implement both the detailed revision of the Health Insurance Act and sub-statutes related to this from November 20th.
- Company
- Celltrion applies for approval of its Eylea biosimilar in KR
- by Jung, Sae-Im Jul 27, 2023 05:40am
- On the 26th, Celltrion announced that it had completed applying for the marketing authorization of 'CT-P42,' its biosimilar to the eye disease treatment ‘Eylea (aflibercept).’ Based on its global Phase III trial, Celltrion applied to be approved for all Eylea indications including as a treatment for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Celltrion confirmed the bioequivalence and similarity of CT-P42 in a Phase III trial that was conducted on 348 patients with diabetic macular edema in 13 countries, including the Czech Republic, Hungary, Poland, and Spain. In June, the company submitted an aBLA (abbreviated biologic license application) for CT-P42 to the US Food and Drug Administration. Starting with Korea, Celltrion plans to apply for approval in major global countries including Europe. Eylea is Regeneron’s blockbuster eye drug that posted global sales of USD 9.76 billion (KRW 12.7 trillion). Eylea’s exclusivity in the US is set to expire in May 2024, and in November 2025 in Europe. A Celltrion official said, “We have confirmed the bioequivalence and similarity of CT-P42 through a global Phase III trial, and applied for marketing authorization to the Ministry of Food and Drug Safety in Korea. In addition to the U.S. and Korea, we will apply for approval in major countries including Europe, and continue to make efforts to expand our biosimilar portfolio in ophthalmology.”
- Company
- Atozet market, ↑ 225% in 2 years
- by Chon, Seung-Hyun Jul 27, 2023 05:40am
- The hyperlipidemic complex drug Atozet prescription market has grown significantly. It more than tripled in two years due to the entry of generic drugs. About 100 generic products increased their market share to 60%, leading the market expansion. Jeil and HK inno. N stood out among generic products. According to UBIST, a pharmaceutical research institute, on the 27th, the outpatient prescription amount of ezetimibe/atorvastatin combination drug in the first half of last year was KRW 126.5 billion, up 33.7% from the previous year. Prescriptions for ezetimibe/atorvastatin combination drugs increased 35.4% YoY to 61.2 billion won in the first quarter and rose 32.1% to 65.3 billion won in the second quarter. Compared to 30.2 billion won in the second quarter of 2021, the prescription amount of the ezetimibe/atorvastatin combination drug in the second quarter more than doubled in two years. As Atozet's generics entered the market in droves, the market size expanded rapidly in a short period of time. Until 2020, the Ezetimibe/Atorvastatin complex was one of Organon's Atozet products. From 2021, more than 100 domestic companies entered the Ezetimibe/Atorvastatin market simultaneously, increasing the market size. In October 2020, Chong Kun Dang received permission for Lipilouzet, a combination drug with the same ingredients as Atozet, after clinical trials. At this time, 22 companies received permission for Lipilouzet's delegated generic products and were listed on the reimbursement list from April 2021. From February 2021, 88 additional pharmaceutical companies received approval for Atozet generics, and they were listed as payroll in May, a month later than Lipilouzet delegated generics. In June 2021, as two additional companies received approval for Atozet generic products, the number of domestic companies entering the Atozet market increased to 113 in total. In the first quarter of 2021, Atozet's prescription amount recorded 20.1 billion won, but as generic products poured in, the ezetimibe/atorvastatin combination market expanded 50.2% to 30.2 billion won in the first quarter. In the second quarter of last year, the prescription volume of the Ezetimibe/Atorvastatin combination soared by more than 224.9% in two years compared to before the introduction of generics. Generic products led the growth of the Ezetimibe/Atorvastatin combination drug market. In the second quarter of last year, Atozet's prescription amount was 25.1 billion won, up 25.0% from the first quarter of 2021, before entering the generic market. This means that the original drug was not affected even by the containment of generic products. In the second quarter of last year, prescriptions for Atozet's generic products were 40.2 billion won, up 46.0% from the same period last year. The share of generics in the ezetimibe/atorvastatin combination drug market reached 61.6%. Atozet's generic products overtook Atozet's prescription volume in the first quarter of last year, one year after its release, and the growth rate accelerated even more this year. The entry of ezetimibe/atorvastatin combination drugs by domestic companies is the result of a competition to preoccupy high drug prices after the implementation of the revised drug price system. According to the stepped drug pricing system, which was implemented as a result of the drug price reform in July 2020, when there are more than 20 identical products listed, the price of generics that enter as latecomers will be lowered by 15%. If there are more than 20 identical drugs already listed, regardless of whether or not the highest price requirement is met, the drug price will be lower between “85% of the drug price that does not meet the two requirements” or “85% of the previous lowest price”. In April 2021, Lipilouzet was listed at the same upper limit as Atozet, the first product with the same ingredient listed. The upper limit of Lipilouzet 10/10mg was registered at 1037 won, the same as Atozet at the time. Of the 21 delegated generics listed at the same time as Lipilouzet, 20 were priced at an upper limit of 85% of the highest price. This is because it did not meet the requirement of the ‘direct bioequivalence test’, which is the highest price requirement for generic products. Generic products must satisfy both the 'direct performance of bioequivalence test' and the 'use of DMF' in order to maintain a 53.55% upper limit compared to original drugs before patent expiration. Each time one condition is not met, the cap is reduced by 15%. Lipilouzet delegated generic 10/10mg 20 products were listed at 881 won, 15% lower than 1037 won. However, all 78 Atozet generic 10/10mg items listed one month later were set at the upper limit of 637 won. The highest price stayed at 61.4% of 1037 won. As ‘85% of the price of drugs that do not meet the two requirements’ is applied according to the step-type drug pricing system, the upper price limit is about 30% lower than that of Lipilouzet’s commissioned generic, which entered the market a month earlier. Among Atozet's generic products, Jeil Pharm's Lipitor Plus stood out with prescriptions of 6.3 billion won in 2Q. Among generic products, Lipitor Plus' share reached 15.7%. Lipitor Plus is jointly marketed by Viatris.
- Company
- Reimb discussions imminent for Obizur in Korea
- by Eo, Yun-Ho Jul 27, 2023 05:40am
- Takeda Pharmaceuticals Korea is quickening its steps to receive reimbursement listing for ‘Obizur,’ its treatment for bleeding episodes in patients with acquired hemophilia A (AHA). According to industry sources, Takeda Pharmaceuticals Korea’s bleeding treatment for adults with acquired hemophilia A may soon be introduced for deliberation at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting in August. As reimbursement evaluations for Obizur have been ongoing immediately after receiving approval in March, the reimbursement process is progressing relatively quickly. Obizur has been designated as an orphan drug in Korea in July 2021. Unlike existing bypass factor drugs, this drug replaces blood coagulation factor VIII with AHA indications. As a gene recombinant therapy that was produced by deleting the B-domain from a porcine factor VIII that is comparable to human Factor VIII, inhibitory antibodies do not readily recognize the treatment. Therefore, Obizur can replace the inactivated human coagulation factor VIII to help blood clotting and control bleeding. The unique mechanism of action allows Obizur to be the only AHA drug that can stably monitor patients’ blood factor VIII levels using standard assays, enabling individually tailored dosing. In a prospective, non-randomized, open-label Phase II/III study of 28 patients with AHA that evaluated the safety and efficacy of Obizur, all patients that were treated with Obizur had a positive response to treatment at 24 hours after initial dosing. A positive response was one where the bleeding had stopped or was reduced, with clinical improvement or with factor VIII activity above a pre-specified target. The treatment success rate after administration of the final dose (within 2 weeks of administration) was 85.7% (24/28), and the rate was higher in patients treated with Obizur as first-line therapy. The treatment success rate was 94% (16/17) in patients treated with Obizur as first-line therapy, and 73% (8/11) in patients treated with Obizur as second-line therapy. No serious adverse events or deaths were observed with Obizur in the study.
- Policy
- NHIS extends Bavencio’s reimb...adds KRW 20 bil sales
- by Lee, Tak-Sun Jul 27, 2023 05:40am
- Merck Korea's 6th immuno-oncology drug, 'Bavencio Inj,’was granted a reimbursement extension and will be covered for the first-line treatment of urothelial cancer from next month. With the reimbursement extension, the drug is expected to secure annual sales worth more than KRW 10 billion like the other immuno-oncology drugs. 'Bavencio is the first drug to be granted reimbursement as a first-line treatment for urothelial cancer. The Health Insurance Review and Assessment Service announced the news through the 'Opinion Inquiry on Amendment to Public Notice for Drugs Prescribed and Administered to Cancer Patients (Draft),’ effective as of August 1st. Bavencio Inj (avelumab) was approved in Korea as the 6th immuno-oncology drug in March 2019. As an anti-PDl-L1 immunotherapy drug, the drug was granted reimbursement for the rare condition, metastatic Merkel cell carcinoma (MCC) in 2020. Currently, a total of 8 immuno-oncology drugs, starting with BMS’s ‘Yervoy (ipilimumab)’ in December 2014, followed by MSD’s ‘Keytruda (pembrolizumab),’ Roche’s Tecentriq (atezolizumab),’ AstraZeneca’s ‘Imfinzi (durvalumab),’ Merck’s Bavencio (avelumbab),’ GSK’s ‘Jemperli (dostarlimab),’ then AstraZeneca’s ‘Imjudo (tremelimumab).’ All immunotherapy drugs other than Jemperli and Imjudo are reimbursed in Korea. Immuno-oncology drugs are breaking new sales records every year, receiving reimbursement extensions based on groundbreaking effects on various types of cancer. Last year, based on IQVIA, Keytruda posted sales of KRW 239.6 billion, Opdivo KRW 109.9 billion, Tecentriq KRW 81.8 billion, Imfinzi KRW 52.4 billion, and Yervoy KRW 14.2 billion. Only Bavencio failed to meet the blockbuster criteria, posting KRW 500 million won in sales last year, but reimbursement as first-line treatment for urothelial cancer approved this time is expected to enable the drug to raise over KRW 10 billion in sales. Urothelial cancer is a common term used to refer to malignant tumors originating from the lining of the urinary system that constitutes the mucosal layer of the urinary tract. It includes bladder cancer, renal pelvic cancer, ureteral cancer, and urethral cancer, with the most frequently occurring cancer being bladder cancer. Platinum-based chemotherapy has been used as the standard first-line treatment, and when the disease progresses or recurs, platinum-based chemotherapy is re-administered or drugs such as Keytruda and paclitaxel were used as second-line treatments. Bavencio is the first immuno-oncology drug to be used as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial cell carcinoma who have not progressed on platinum-based chemotherapy. The NHIS estimated the number of urothelial cancer patients that would use Babencio to be about 670 per year and agreed with the pharmaceutical company on the estimated claims amount of KRW 21.65 billion. In other words, the reimbursement extension guarantees additional sales of KRW 20 billion won per year. However, actual sales are expected to be less as the company signed a refund type and expenditure cap type risk-sharing agreement (RSA). Bavencio also lowered its insurance price ceiling by 30% with the reimbursement extension, from KRW 1,226,243 per vial to KRW 854,864 per vial. However, Bavencio’s reimbursement extension is not expected to significantly affect insurance finances. Rather, it is expected to have the effect of saving NHI finances. This is because of the amount of Keytruda used. NHIS expects the use of Keytruda, which is being used as a second-line treatment for urothelial cancer, will decrease with the reimbursement extension of Bavencio. Immunotherapy drugs cannot be administered in the second line if another immunotherapy drug is used as first-line maintenance therapy. Therefore, the NHIS estimated that the actual amount of fiscal spending, unlike the expected claims amount, will range between KRW -1.84 billion to KRW 5.57 billion. Currently, Keytruda is granted reimbursement for 7 indications in 4 cancer types, including as a first-line treatment for metastatic non-small-cell lung cancer. In addition, as it has recently applied to extend reimbursement to 13 indications, its use in cancer is expected to expand further in the future. Therefore, the reimbursement authorities will have to continue to contemplate ways to minimize the spending of health insurance finances while expanding the reimbursement of effective immuno-oncology drugs.
- Company
- Astellas launches urothelial cancer drug Padcev
- by Kim, Jin-Gu Jul 26, 2023 05:41am
- Astellas officially launched 'Padcev' in Korea as a drug to treat locally advanced or metastatic urothelial cancer. Astellas Pharmaceutical Korea held a press conference to commemorate the launch of Padcev in Korea at the Intercontinental Hotel in Seoul on the 19th. Urethral carcinoma is a type of bladder cancer. It is estimated that 90% of bladder cancers are urothelial carcinomas. The survival prognosis is not known to be good. Non-muscle invasive bladder cancer that does not invade the bladder muscle has a 5-year relative survival rate of 80%. However, if the cancer invades the bladder muscle, the 5-year relative survival rate drops sharply to 50%. In particular, about half of them lead to distant metastasis. At this time, the 5-year relative survival rate is further reduced to 5%. Patients receive platinum-based chemotherapy as first-line treatment and PD-1 or PD-L1 inhibitors as second-line treatment. However, in the case of platinum-based chemotherapy, which is the first-line treatment, low tolerance and high possibility of disease progression were cited as problems. Immunotherapy that can be considered as a second-line treatment showed that only 13-28% of patients responded to treatment regardless of PD-L1 status. As a result, most of the disease progressed within 3 months of treatment. Padcev is a treatment that can be used for patients whose cancer has progressed or relapsed after chemotherapy (first-line treatment) and immuno-anticancer drugs (second-line or first-line maintenance therapy) in situations where treatment options are not feasible. Padcev is an antibody-drug conjugate (ADC) that targets nectin-4. In March of this year, it was approved as monotherapy by the Ministry of Food and Drug Safety. It is first recommended as Category 1 in the NCCN Guidelines. The Padcev phase 3 trial was conducted by comparing and evaluating Padcev with existing chemotherapy drugs in 608 patients with locally advanced or metastatic urothelial cancer. As a result, it was found that the Padcev administration group reduced the risk of death by about 30% compared to conventional chemotherapy. The median overall survival (OS) of the Padcev-administered group was 12.9 months, which was 3.97 months longer than the chemotherapy group, demonstrating a significant improvement in survival time. In addition, the median PFS of the Padcev-administered group was 5.6 months and that of the control group was 3.7 months, indicating a 37% reduction in the risk of disease progression. Kim Mi-so, a professor of oncology at Seoul National University Hospital, said, "Platinum-based chemotherapy is mainly based on cisplatin. However, the PFS ranges from 7.7 to 9.5 months, so most of the disease progresses within a year." Professor Mi-So Kim said, “Second-line PD-1/L1 inhibitors are recommended for patients whose disease has progressed after the first-line platinum-based chemotherapy, but most patients do not respond to treatment.” Park Kyung-ah, director of Astellas Pharmaceuticals Korea, said, "We will operate the patient program until Padcev is covered by reimbursement." Kim Joon-il, CEO of Astellas Pharmaceuticals Korea, said, “We are delighted to be able to release Padcev as early as possible.” "With Padcev, we will be able to provide innovative treatment options to patients with locally advanced or metastatic urothelial cancer in Korea," he said.
