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- 2026-05-14 05:31:35
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- Concerns over Leclaza's sluggish secondary indicators
- by Dec 06, 2022 05:57am
- This is in contrast to the significant improvement in the primary indicator, the progression-free survival period (PFS). We cannot rule out the possibility that a similar situation to Tagrisso, whose effectiveness was questioned by the Asian OS, will be reproduced. The global clinical director (PI) explains that it is not easy to secure statistical significance due to the relatively high ratio of crossover converted to third-generation treatments due to confirmed resistance mutations among control patients. Cho Byung-chul, a professor of oncology at Yonsei Severance Hospital, who oversees LASER301 clinical trials, said at a press conference held in Singapore on the 3rd (local time), "Leclaza failed to meet the statistical significance of OS improvement because there was a high crossover rate of about 40 percent," adding, "There is no room for resistance change now." Professor Cho Byung-chul (left) and Professor Ross Su (right) explain the clinical results of phase 3 of Leclaza LASER301 is a global study that confirmed the effectiveness and safety of the first-generation treatment "Iressa" when Leclaza was used as the first treatment for EGFR-mutated non-small cell lung cancer patients. The first evaluation index was the progression-free survival period (PFS), and Leclaza recorded a 20.6-month PFS, which reduced the risk of disease progression and death by 55% compared to the control group, demonstrating high improvement. OS, the secondary indicator, has 29% data maturity, and sufficient data has not been collected. However, the survival rate of Leclaza at 18 months after administration was not statistically significant compared to the control group (p=0.116). At the time of 29% of data collection, 25% (49) of the Leclaza group died, and 32% (64) of the control group died. Looking at the trend of the graph of the total survival period released on this day, the survival rate of the Leclaza group and the control group becomes almost similar from 27 months after administration. The final OS data will be released at the end of next year. Leclaza phase 3 clinical overall survival graph (29% maturity). (Source: ESMO) Professor Cho explained that the high rate of crossover in the control group that received the first-generation treatment affected Leclaza's OS. Crossover refers to allowing patients classified as control groups to take other treatments at an ethical level if they do not see treatment effects due to resistance during the administration of control drugs. In phase 3 clinical trials, 24% (47) of 197 control groups changed the treatment to Leclaza through crossover. 12% (24) stopped clinical trials and administered other treatments. A total of 71 people (36%) stopped administering control drugs and switched to third-generation treatments. Tagrisso, the first 3rd generation EGFR formulation conducted earlier, was also affected by the OS by allowing crossover at the time of phase 3 clinical trials. Tagrisso Japan Real World Data The 40.9-month OS dispelled concerns caused by phase 3 data (Source: ESMO) Tagrisso demonstrated OS improvement over controls but failed to improve OS in Asian subgroups (HR=0.995). At that time, 85 (31%) of 277 patients in the clinical control group stopped administering first and second-generation treatments and received Tagrisso as a follow-up treatment, which caused "data bias." Because of this, Tagrisso's effectiveness was questioned by Asians. Concerns have been raised that Tagrisso's OS benefits are unclear in Asians. Tagrisso has also been pointed out as the main reason why it has not been listed on the domestic primary benefit so far. The effectiveness of Tagrisso is being proven in clinical practice. According to the recently released Real World data in Japan, Tagrisso recorded an OS of 40.9 months for more than three years. About 90% of EGFR-mutated non-small cell lung cancer patients in the United States and Europe as well as Japan are being treated with Tagrisso in the first round. Leclaza was also influenced by the clinical environment where the diagnosis of T790M mutations, the first and second generations of resistant mutations, became active. Professor Cho said, "At the time of phase 3 of Tagrisso, the T790M mutation itself was unfamiliar. Naturally, the diagnosis was not active. However, now, follow-up treatments have emerged and T790M tests are being actively conducted. Because of this, nearly 40% of patients were crossover. In other words, as resistance diagnosis was actively conducted, more patients were found to receive follow-up treatment. He added, "Leclaza's higher OS effect was observed when analyzed by applying the IPCW (Inverse Probability of Sensing Weight) technique." The IPCW technique refers to an analysis that minimizes "bias" by correcting crossover patient data. Professor Cho said, "I don't think the failure of OS to secure statistical significance will lead to concerns over the Leclaza effect." Ross A. Soo, a professor at the National Cancer Center in Singapore, also said, "It is still too early to evaluate OS, and the effectiveness of individual drugs can be confirmed by PFS indicators, and OS is an indicator of the entire treatment, including follow-up treatment."
- Policy
- The government is conducting six studies on drug prices
- by Kim, Jung-Ju Dec 06, 2022 05:57am
- With a number of drug price systems in operation within the positive list system, the government is conducting six studies on drug price policies related to insurance benefit entry permits and follow-up management, drawing attention to how the results will be reflected next year. According to the Ministry of Health and Welfare, this year, the insurance authorities are conducting six studies on the ▲ actual transaction price system, ▲ low-priced purchase incentive system, ▲ PVA improvement, ▲ RSA performance evaluation and future improvement, ▲ drug price adjustment system, and ▲ plasma raw materials. These studies are expected to be an important basis for the reorganization or improvement of the government's drug price policy because the main goal is to check the need for policy improvement and present improvement plans. In fact, Oh Chang-hyun, head of the insurance drug division at the Ministry of Health and Welfare, said, "These studies, which started this year, will be completed by early next year. Although improvement plans for the systems may be drawn, it is not known at present whether they can all lead to implementation, he said. "There will be some that can lead to improvement of the system next year and some that will be delayed further." The Ministry of Health and Welfare said that even if the foundation of these studies was to improve spending efficiency, they did not include any new drug price reduction measures. In other words, this also means that the Ministry of Health and Welfare will maintain the existing policy among the Trade-Offs that have been used as the keynote for recent years in next year's policy projects. Manager Oh said, "We have not discovered a new system (to do next year). Since the drug price system has changed a lot in 2020, we are working on follow-up work to make it well realized, he said. "We will continue to maintain this stance because we need to increase drug access for severely rare and intractable patients with reduced costs."
- Company
- Rozlytrek can be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Dec 06, 2022 05:57am
- Rozlytrek can be prescribed in big 5. According to related industries, Rozlytrek, a target anticancer drug for NTRK in Roche, Korea, passed the DC of Big 5, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Bayer Korea's Vitrakvi has already entered the Big 5 hospitals, and both drugs have been covered by insurance benefits since April this month, so competition for full-fledged prescriptions has begun. The two drugs can actually be applied to most carcinomas where the NTRK gene has been identified. However, there are restrictions on standards. The subjects of salary administration of the two drugs were limited to cancer types mentioned in the NCCN guidelines. Rozlytrek, approved in Korea as a rare drug in April 2020, can be prescribed for solid cancer in adults and children aged 12 or older with NTRK gene fusion without acquisition-resistant mutations, and local progressive or metastatic non-small cell lung cancer, which is positive for ROS1 in adults. Rozlytrek's permission was determined based on clinical Phase 1/2 STARTRK-NG trials in pediatric patients and data from STARTRK-2, a major phase 2 clinical trial, and STARTRK-1 and ALKA-372-001 trials in clinical phase 1. In the STARTRK-2 study, Rozlytrek reduced tumors in more than half to 56.9% of patients with solid cancer positive for NTRK fusion genes. Patients were conducted on 10 different solid cancer patients, and the response duration was observed to be 10.4 months. At the International Conference of the World Lung Cancer Society in August, the results of an additional integrated analysis of Rozlytrek's major clinical studies conducted on patients were released. In this integrated analysis, Rozlytrek's objective response rate (ORR) was 67.4% in all patients, 63.3% in patients with cerebral metastasis, 69.6% in patients with non-brain metastasis, and 68.7% in patients with first-treatment. The progression-free survival (PFS) and overall survival (OS) were 16.8 months and 44.1 months, respectively, but there was no significant difference between the first-treatment patient group and the entire patient group.
- Policy
- "A9 countries not used for drug pricing reevals next year"
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- The government announced that it will not immediately apply its plan to increase the number of foreign drug price reference countries by 2 in its reevaluations next year. The foreign reference drug pricing system is essentially used to evaluate the price of reimbursed drugs in Korea. Also, regarding the pharma-bio industry’s concern, the government firmly said using the A9 price as a reference for unilateral drug price cuts in the future does not fit the purpose or objective of the system. At a recent meeting with the multinational pharmaceutical company press corp, Oh Chang-Hyun, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, said so regarding questions on the MOHW’s plan to expand the number of foreign drug price referencing countries. According to the government, the currently used drug price decision method has an unclear reference basis, so the MOHW commissioned a research service for 'Measures for Improving Foreign Drug Price Reference Standards' in 2019, based on which it prepared the revision plan. The plan was part of the 1st Comprehensive Plan of National Health Insurance. The research service results proposed the inclusion of Taiwan, Australia, and Canada in the current A7 (US, UK, France, Germany, Italy, Switzerland, and Japan). The government decided to amend the current standards by including Canada and Australia, countries that have similar or slightly smaller economic levels and pharmacuetical industry scales, and review the price calculation formula. Director Oh said, “We included the two countries that evaluate the economic feasibility of public health insurance through HTA (health technology assessment) as these countries assess drug price based on clinical usefulness.” The government and the Health Insurance Review and Assessment Service are collecting industry and expert opinions on systemic reform. According to Director Oh, the industry opinion inquiry that is set until the 11th is the first official external opinion inquiry being issued for the system. The industry’s concerns are clear. Australia and Canada’s drug prices are generally lower as they are not new drug developing countries, therefore referring to the price of these countries will naturally lower Korea’s price level and reduce the drive for new drug development. The area that the industry worries the new system may soon be applied was in the reevaluation of patent-expired drugs next year. Also, the industry expressed concerns about how the system may be further applied to unilateral drug price cuts in the future. Adding on to the concerns, the possibility remains that applying the steeped pricing system may further reduce the drug price. Regarding concerns over reevaluations, Director Oh clearly stated that it is physically impossible for the revision to be applied next year for patent-expired drug reevaluations. Director Oh said, “We need to prepare around 1 year in advance to conduct such reevaluations, In other words, we need to make announcements a year in advance. As we have not made any announcement until now, it is impossible to conduct reevaluations next year.” Also, another reason is that the government nor HIRA has the resources to conduct the reevaluation as large-scale reassessments on reimbursement adequacy of drugs are already set to be conducted next year. Director Oh said, “We are not ready to conduct foreign drug price reevaluations next year as the reevaluation of drugs that have submitted bioequivalence data (reevaluation of reimbursed drug prices for already-listed bioequivalence test subjects) and reevaluation of reimbursement for 8 ingredients are in progress." Also, Oh added that applying the A9 countries for unilateral drug price cuts will not be feasible as it does not meet the purpose or objective of the revision. "Using our plan to reevaluate the foreign drug reference system and applying it to unilateral price cuts does not fit the purpose of our reform. The government never mentioned that it will be used for unilateral price cuts.”
- Policy
- Implementation of projects linked to permission evaluation
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- The government will conduct a pilot project of the "Permission Evaluation Negotiation Linkage System" in the first half of next year, which will simultaneously carry out three tracks of the drug market-wage hurdles, including the Ministry of Food and Drug Safety's item license safety and efficacy evaluation and the NHIS drug price negotiation. Although detailed standards or appropriate drug candidates have not yet been set, the pharmaceutical industry is showing interest, and the process will be created as soon as possible and applied as soon as appropriate drugs appear in the first half of the year. The Ministry of Health and Welfare recently announced the business plan when asked about pending insurance drug issues by the Korea Special Press Association. The government is currently operating the drug approval-patent linkage system to strengthen accessibility to patients. The drug approval-patent linkage system is a system that allows insurance benefits to be applied quickly by drastically reducing the time required by the Ministry of Food and Drug Safety's product approval and the HIRA benefit adequacy evaluation stage. Usually, the Ministry of Food and Drug Safety's review of the safety and effectiveness of drugs must be passed and item permission must be obtained to apply for insurance registration by the Korea Appraisal Board. If the salary adequacy is determined here, it will be reported to the Health Insurance Policy Review Committee immediately after the drug price negotiation of the industrial complex or if the salary is confirmed by formula, the final registration will be decided. Negotiations have been added to the permit evaluation linkage system, one of the "fast tracks" listed in the drug, which reduces the time further as a total of three tracks are conducted in parallel at the same time. The target is a drug that has a short life expectancy of ▲ from 6 months to less than 1 year, meets ▲the number of patients with cancer, and rare diseases, and has ▲ sufficient improvement effects instead of alternative drugs. Judging from what pharmaceutical companies are inquiring about, Oh seems to have drugs included in the target category. He added, "We will start a pilot project next year, we will organize the process as soon as possible and start it as soon as possible." He said, "I think it's the first half of the year, but I haven't decided on the candidate group or the details yet." He said, "We can set up a candidate group for pharmaceutical companies. "We will start in the first half of the year," he said. The government plans to effectively operate the Drug Approval-Patent Linkage System, which is currently in operation. This is because the existing system has also proven effective in improving drug accessibility. Manager Oh added, "Even if the Drug Approval-Patent Linkage System is introduced, the existing Drug Approval-Patent Linkage System will be taken as it is."
- Policy
- MOHW “reasonably decide on using A9 countries as reference"
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- # i1 Regarding criticism from the industry on how the systemic reform of adding Australia and Canada to the existing A7 countries as drug price reference countries that are used for new drug insurance reimbursement evaluations, the government said it would make a reasonable decision after collecting industry and expert opinion. The Ministry of Health and Welfare released an explanation on the afternoon of the 2nd and emphasized that the revised plan was made as a result of lengthy discussions with the pharmaceutical industry and working-level consultative bodies. On November 21st, the Health Insurance Review and Assessment Service made a preannouncement of its revision plan to officially expand the number of reference countries used to evaluate new drugs from 7 to 9 (US, UK, Germany, France, Italy, Switzerland, Japan, Canada, Australia·A9) through the ‘Proposal for the Amendment to the Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits.’ Until now, the government had referred to the insured drug price of A7 countries when negotiating, agreeing, or designating insurance drug prices in Korea to not exceed the level set in A7 countries. Following the announcement, concerns and criticisms from interested parties arose on how adding Australia and Canada, which are not strong new drug developers, to the reference countries will decrease the price of insured drug prices in Korea and adversely affect the domestic pharmaceutical and bio-industry. On this, the MOHW explained that “The currently used drug price decision-making method has an unclear reference basis, so the MOHW organized a working-level consultative body with the pharmaceutical industry for 4 months from May this year based on the results of the policy research conducted in 2019 and expert consultation.” The MOHW added, “We will reasonably review various opinions that are submitted during the opinion inquiry period according to relevant procedures until the 11th, and then collect expert opinions to make a final decision." Meanwhile, the MOHW said that no specific plan has yet been set for the reevaluation of listed generics based on the revisited A9 plan and that it will provide information on the issue after collecting relevant opinions from the pharmaceutical industry.
- Policy
- The safety & efficacy evaluation of Jemperili was terminated
- by Lee, Hye-Kyung Dec 05, 2022 05:53am
- Authorization of domestic items for GlaxoSmithKline's immuno-cancer drug Jemperili is imminent. According to the pharmaceutical industry on the 1st, the Ministry of Food and Drug Safety recently ended Jemperili's safety and efficiency evaluation. As the safety and efficacy evaluation has been completed, permission will be obtained soon if there are no other variables. If Jemperili is approved, it will be listed as the third PD-1 inhibitor after Opdivo of Ono and BMS and Keytruda of MSD. Jemperili is the pipeline GSK acquired in 2019 when it acquired Tesaro for $5.1 billion. Unlike Opdivo and Keytruda, which had their first indication as melanoma treatments, Jemperili approved conditional sales of Jemperili in the EU in April last year, following the first approval in the U.S. as a treatment for recurrent or progressive endometrial cancer indicating "platinum-based therapy or subsequent inconsistency recovery defects." FDA approval was based on the results of the dMMR endometrial cancer cohort of the ongoing Phase 1 clinical trial GARNET study. The overall response rate of 71 patients with dMMR recurrent/progressive endometrial cancer in the study was 42.3%, with 12.7% and 29.6% for complete remission (tumor extinction) and partial remission (tumor contraction), respectively. In August of the same year, Jemperili obtained additional approval for dMMR recurrence or advanced various solid cancers that did not reach satisfactory results with existing treatment. GSK plans to add indications after endometrial cancer in Korea. Meanwhile, Keytruda and Opdivo, approved as domestic immuno-cancer drugs 1 and 2, are actively working on adding indications and expanding benefits.
- Policy
- Domestic new drug No. 36 Envlo has been approved
- by Lee, Hye-Kyung Dec 05, 2022 05:53am
- Envlo 0.3mg, the 36th domestic development new drug, has been approved in Korea. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 30th that it has approved Daewoong Pharmaceutical's Envlo to improve blood sugar control in patients with type 2 diabetes. Envlo is an adjunct to diet and exercise therapy administered to improve blood sugar control in type 2 diabetes patients. It lowers blood sugar by suppressing the reabsorption of glucose in the kidneys and allowing glucose to be released into the urine. It selectively inhibits sodium-glucose co-transporters (SGLT2 transporters) involved in the re-absorption of glucose in the kidney (neoprene tube) to block the re-absorption of glucose into the bloodstream. Currently licensed SGLT2 transporter inhibitors include Dapagliflozin, Ertugliflozin, Empagliflozin, and Ifragliflozin. The Ministry of Food and Drug Safety said, "We expect this approval of the new drug to help expand the scope of treatment options and treatment opportunities for type 2 diabetes patients. The Ministry of Food and Drug Safety will continue to do its best to expand treatment opportunities to patients by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- InterView
- The issue of SE of JAK inhibitors should be given authority
- by Kim, Jin-Gu Dec 02, 2022 06:08am
- Shim Seung-cheol, professor of rheumatology at Chungnam National University HospitalThe treatment results of rheumatoid arthritis have improved dramatically. This is because doctors can use it a lot. Following the advent of MTX in the late 1980s, TNF-alpha inhibitors changed the treatment paradigm of this disease. Recently, JAK inhibitors that improved the shortcomings of TNF-alpha inhibitors have emerged. JAK inhibitors, which have been attracting attention as next-generation treatments, have recently been at the center of controversy due to safety issues. This is because concerns have been raised that the drug may cause cardiovascular side effects. How do the prescription sites view the safety issue of JAK inhibitors? Shim Seung-chul, a professor of rheumatology at Chungnam National University Hospital, said, " We should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." He said, "If clinical data are added to confirm which patients are more likely to have drug side effects, detailed treatment guidelines for JAK inhibitors will be prepared." ◆ One in 10 patients is difficult to treat with MTX or TNF-alpha inhibitors Rheumatoid arthritis is an autoimmune disease. Treatment is also carried out in a way that suppresses autoimmune phenomena. The most traditional treatment is MTX. It is a drug that suppresses lymphocytes and was initially more commonly used as a treatment for leukemia. Since it was approved for the purpose of treating rheumatoid arthritis in 1988, it has been used for more than 30 years. Since it was originally developed as an anticancer drug, there were many patients whose drug did not work. In time, a better treatment was developed. It is a TNF-alpha inhibitor. It not only inhibits one target that causes autoimmune diseases but also inhibits several parts at the same time. Since the advent of this drug, the treatment results of rheumatoid arthritis have improved dramatically. The limitations of TNF-alpha inhibitors were also pointed out. The number of patients who do not respond to this drug has gradually increased. The disadvantage of injection was also pointed out. Patients with mobility difficulties due to arthritis wanted to treat the disease more comfortably by reducing hospital visits. JAK inhibitors have emerged. The method of suppressing inflammation has also improved. If existing drugs were a method of blocking inflammatory substances outside the cell, JAK inhibitors are a method of accurately targeting and suppressing substances within the cell. Professor Shim said, "The use of MTX is effective in 70% of patients. If there is no reaction here, using TNF-alpha inhibitors improves 70% of them. He said, "10% of all patients were difficult to treat. Unlike TNF-alpha inhibitors, the development of JAK inhibitors that block inflammatory signals in cells has made it possible to treat such patients. ◆MTX also experienced side effects of TNF inhibitors…JAK inhibitors can also be overcome Safety issues have recently emerged in JAK inhibitors, which have emerged with high expectations. In 2021, the U.S. Food and Drug Administration (FDA) warned of risks such as heart disease and cancer against JAK inhibitors, and the MFDS in Korea also distributed safety letters. Eventually, the FDA decided to include risk information such as major cardiovascular events, thrombosis, and death in the box warning in the JAK inhibitor. Professor Shim Seung-chul said, "The existing drugs have undergone a similar process," adding, "What is important is how well you manage side effects and treat diseases." "I think we can overcome the problems that are currently being raised," he said. According to him, MTX has had side effects such as an increase in liver levels since its appearance. Accordingly, drugs were used at the prescription site while simultaneously performing a liver biopsy. As the experience of use accumulated, the drug has been set up to be prescribed in low doses when used for rheumatoid arthritis rather than anticancer drugs. The same is true of TNF-alpha inhibitors. Concerns have been raised that it causes tuberculosis in the early stages of its appearance. These concerns were addressed by the use of anti-tuberculosis drugs. In the case of JAK inhibitors, concerns about herpes zoster were raised at the beginning. Professor Shim explains that the newly emerged cardiovascular risk can also be seen as an extension of this. Professor Shim said, "We need to pay attention to the extent to which side effects occur frequently in certain patients, not in the side effects themselves," adding, "We expect that detailed treatment guidelines for JAK inhibitors will be prepared when more domestic clinical data are accumulated and drug side effects occur. JAK inhibitors are limitedly used only when other drugs do not work. If drugs are used sequentially, there will be no big problem. I think we should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." There are three representative JAK inhibitors released in Korea. In the case of Xeljanz, it is a general-purpose JAK inhibitor that inhibits all three inflammatory substances. Olumiant inhibits two substances and Rinvoq SR inhibits one substance. Professor Shim said, "There are currently various JAK inhibitors released, and further research is needed to find out the difference between general-purpose JAK inhibitors that suppress all inflammatory substances in cells and selective JAK inhibitors that suppress only certain substances."
- Company
- Leclaza P3T results unveiled... mPFS 20 months
- by Dec 02, 2022 06:07am
- The abstract data from a global Phase III trial on ‘Leclaza (lazertinib),’ the 31st homegrown novel drug developed by Yuhan Corp, has been released. In the trial, Leclaza improved progression-free survival (PFS) by 11 months compared to the existing treatment Iressa and met the primary endpoint. The study results of LASER301 above that assessed the safety and efficacy of Leclaza as first-line treatment in EGFR (epidermal growth factor receptor) mutant-positive NSCLC were released with other major study results on the 1st at the ESMO ASIA Congress 2022. LASER301 is a global Phase III trial that evaluated the efficacy and safety of Leclaza as first-line treatment in locally advanced or metastatic NSCLC patients with EGFR mutations. The trial enrolled 393 patients in 13 countries and compared Leclaza with the existing treatment, ‘gefitinib (brand name: Iressa).’ The primary efficacy endpoint was progression-free survival (PFS). The secondary endpoints were objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and overall survival (OS). In terms of median PFS (mPFS), the primary efficacy endpoint, Leclaza’s mPFS was 20.6 months, a significant improvement over the 9.7 months in the control group. The drug also reduced the risk of disease progression and death by 55%. The PFS improvement was consistently observed in all predefined subgroups (Asians and non-Asians, Exon19del or L858R mutation, etc.). Leclaza’s DoR was 19.4 months, significantly longer than the 8.3 months in the control group. ORR was 76% in both treatment groups. The OS data has not matured yet (maturity 29%). At 18 months after administration, the lazertinib arm’s survival rate was 80%, higher than the 72% in the control group but did not reach statistical significance (p=0.116). Regarding its safety, lazertinib and Iressa showed a consistent safety profile with those that had been previously reported. The results of the LASER301 study will be presented at the ESMO ASIA Congress 2022 which will be held on the 3rd in Singapore. Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year. It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells. It is currently approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. Yuhan Corp conducted the global Phase III trial to expand the drug’s indication to first-line treatment in EGFR mutated lung cancer. The results greatly increased the possibility of the drug extending its indication to first-line in Korea. In Korea, Leclaza’s cumulative sales exceeded KRW 10 billion in only 1 year since its release with insurance reimbursement. If approved in the first line, its increase in sales is expected to accelerate further. Trials on its combined use with other drugs are also actively underway. Yuhan Corp had made a licensing deal with the global pharmaceutical company Janssen. Janssen has been developing the drug in combination with its own EGFR-MET bispecific antibody ‘Rybrevant (amivantamab).’
