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- 2026-04-16 08:12:13
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- Galderma Korea appoints Younhee Kim as the new CEO
- by Eo, Yun-Ho Sep 03, 2020 12:55pm
- Galderma Korea has appointed Younhee Kim, former general manager of the Medical Solution Division, as the new CEO. According to related industries, CEO Kim started official business as the official president on the October 1st. Rene Wipperich, former CEO of Galderma's Korean subsidiary for two years from September 2018, has been confirmed to have moved to a Swiss subsidiary. Galderma Korea was transformed into a Korean president system about two years after former CEO Heung Bum Park resigned. CEO Rene Wipperich joined Nestlé, a Galderma holding company in 1999, and served as general manager of commercial operations at Nestlé's headquarters after representing Malaysia and Singapore, as well as representing Indonesia. The new CEO Kim has accumulated her career as a marketing manager in the women's business unit and vaccine business unit after working at MSD Korea. Afterwards, she served as Marketing Head of Merz Korea, experiencing the skin and beauty field, and until recently led the Medical Solution Division at Galderma's Korean subsidiary. Meanwhile, last year, Galderma became independent from its parent company Nestlé Healthcare Division after 28 years of inauguration. The change in ownership was due to the Swedish private equity EQT VIII fund (EQT), Luxinva and PSP Investments, a 100% subsidiary of the Abu Dhabi Investment Authority (ADIA), and a consortium of renowned institutional investors. It was completed under an exclusive negotiation with its former owner Nestlé SA. Since then, Galderma has been providing various medical solutions and solutions for consumer skin health through a total of two business units: the medical solution business unit including the pharmaceutical business unit and the aesthetic business unit, and the consumer care business unit.
- Policy
- DREC and Cancer Committee to convene more on-paper meetings
- by Lee, Hye-Kyung Sep 03, 2020 06:29am
- The South Korean government is to alleviate on-paper deliberations related regulation for the first threshold of pharmaceutical reimbursement listing—the Drug Reimbursement Evaluation Committee (DREC) and Cancer Deliberation Committee. The Health Insurance Review and Assessment Service (HIRA) preannounced partially revised managerial regulation on the committee that loosens and amends on-paper review regulations. Relevant public opinions would be accepted until Sept. 7. HIRA regularly convenes DREC meeting on every first Thursday of a month, and Cancer Deliberation Committee has scheduled eight meetings for the rest of the year. Amid COVID-19 pandemic, however, DREC and Cancer Committee meetings were postponed or delayed the decision making on drug reimbursement listing due to the regulation limiting on-paper review to two consecutive times. As a result, patients and pharmaceutical companies’ complains have snowballed. Accordingly, HIRA has decided to alleviate the on-paper review regulation stipulated in DREC and Cancer Committee managerial regulations. The current regulation stipulates, ‘a deliberation can be conducted on-paper, in case of urgent or non-critical case, but the on-paper review and deliberation cannot be conducted more than two consecutive times.’ The newly revised regulation would allow on-paper review and deliberation ‘in case the committee chair decides an in-person meeting cannot be convened for urgent or unavoidable reasons, or more than one-third of the registered committees have requested for on-paper deliberation with the attached No. 9 template.’ HIRA official stated, “The on-paper deliberation related regulation would be alleviated to efficiently operate the committees,” and “the revisions were made based on similar regulations in other Expert Evaluation Committees.” When finalized, the latest amendment aims to improve the continuity of tasks such as drug listing or reimbursement expansion, when in-person review is unfeasible due to a threat to public health like COVID-19.
- Policy
- Celltrion's COVID-19 antibody treatment phase I completed
- by Lee, Tak-Sun Sep 03, 2020 06:27am
- The MFDS announced on the 1st that the COVID-19 antibody treatment drug Celltrion is developing has completed phase I clinical administration and is currently under review of phase II/III trial plans. The MFDS announced the progress of the COVID-19 treatment and vaccine clinical trials in the explanatory data. Celltrion's new drug (CT-P59) for neutralizing antibody therapy (CT-P59), has been administered in phase I clinical trials in healthy people, and plans for phase II/III clinical trials are currently under review. Celltrion is recruiting patients with approval for a phase I clinical trial in the UK as well. The 'Plasma Fractionation Treatment' developed by GC Pharma, which was approved for a phase II clinical trial on the 20th of last month, is scheduled to conduct a clinical trial for patients with COVID-19 symptoms within 7 days from September at 6 hospitals including Samsung Medical Center. Specifically, plasma fractionation therapy will be administered to 15 patients per group at low, medium, and high doses in addition to the existing treatment for pneumonia patients identified by imaging diagnosis, patients 70 years of age or older, and patients with underlying diseases over 60 years of age. According to the MFDS, there are currently 22 clinical trials approved in Korea (20 treatments, 2 vaccines). Of these, 5 treatment clinical trials have been completed, and a total of 17 clinical trials currently in progress (15 treatments, 2 vaccines) In addition, 12 clinical trials are being conducted by pharmaceutical companies, and 5 clinical trials are being conducted by researchers. The MFDS announced that it is in the process of prompting national shipment approval with the aim of supplying approximately 30 million seasonal flu vaccines, up 20% from last year, in preparation for the simultaneous outbreak of seasonal flu and COVID-19. Through this, it plans to ship more than for 26 million people before September 22, when the NIP program starts in earnest.
- Policy
- IND for AK-216 (Vildagliptin) by Alvogen Korea was approved
- by Lee, Tak-Sun Sep 03, 2020 06:27am
- Galvus by NovartisAlvogen Korea is launching a phase III clinical trial of Vildagliptin, a diabetes treatment of DPP-4 inhibition. It is entering phase III in 9 months after approval of clinical trial I in November of last year. However, the effectiveness with Metformin, not monotherapy, are verified. While generics for Galvus are aiming for an early release through a patent challenge, it is noteworthy whether they will fall into an ambush On the 31st of last month, the MFDS approved the Phase III Clinical Trial Protocol (IND) for AK-216 (Vildagliptin) by Alvogen Korea. Type of AK-216 is known as a sustained-release tablet taken once a day. Currently, the original drug Novartis' Galvus 50mg requires a total of 100mg twice a day. AK-216 is expected to improve patient convenience by reducing the dosage. This clinical trial demonstrates the efficacy and safety of Vildagliptin SR tablet (AK-216) compared to Vildagliptin (Galvus) when Vildagliptin is administered concurrently to patients with type II diabetes who have insufficient blood sugar control with Metformin alone. It is conducted for comparative evaluation. It is scheduled to be conducted at the Asan medical center in Seoul for 356 patients in Korea. Currently, the material patent of Galvus 50mg is scheduled to expire on March 4, 2022. Ahn-gook and Hanmi succeeded in invalidating 187 days at the Intellectual Property Trial and Appeal Board through a request for invalidation of an extension of the duration, laying the foundation for launching from August 30 next year. However, the decision of the Patent Court, which can be called an appeal trial, is scheduled soon, so the outcome cannot be predicted. In addition, Hanmi has devised a strategy for splitting indications, but it was canceled after the Intellectual Property Trial and Appeal Board dismissed the claim in July. Alvogen's sustained-release tablet is expected to complete phase III clinical trials in line with the expiration of the material patent. Even if Ahn-gook and Hanmi launch generic for Vildagliptin in advance, it is likely that the preoccupation of Alvogen's product will be less affected. Alvogen has been using a strategy to supply developed IMD to other companies through licensing out. Accordingly, it is expected that Vildagliptin SR tablet will receive attention from the various pharmaceutical companies. Galvus recorded an outpatient prescription amount of ₩8.7 billion last year according to UBIST.
- Policy
- 2021 MOHW budget KRW 90.15 tln--KRW 131 bln on COVID-19
- by Kim, Jung-Ju Sep 03, 2020 06:27am
- South Korea’s Ministry of Health and Welfare (MOHW) has finalized next year’s budget plan with 90 trillion won. The state funding for National Health Insurance (NHI) has been raised to 9.5 trillion won. 131.4 billion won was allocated on providing support on R&D seeking COVID-19 treatment and vaccine. Moreover, the state-led new drug R&D program’s budget has increased by 15.1 billion won, and pharmaceutical industry development support was increased by 1.1 billion won to 16.1 billion won. MOHW stated on Sept. 1 that 90.15 trillion won, with 9.2 percent increase compared to this year, has been appropriated for the 2021 budget plan to mainly enhance public health risk response capacity, expand public medicine facility and improve platform for the ‘Inclusive State.’ The government’s projected overall expenditure in 2021, passed by the Cabinet meeting on Sept. 1, would grow by 8.5 percent from this year to 555.8 trillion won. Within the budget plan, MOHW’s projected overall expenditure is to reach 90.15 trillion won, with 9.2 percent increase from this year. The projected figure would take up 16.2 percent of the overall government expenditure. ◆Enhancing public health risk response capacity—R&D on infectious diseases: The government has allocated budget to assist developing COVID-19 treatment and vaccine, and to upgrade equipments for infectious disease control. Total budget of 131.4 billion won, consisting of 62.7 billion won on treatment and 68.7 billion won on vaccine, were finalized. Additionally, 16.5 billion won would be injected for upgrading infectious disease control equipment and testing kit, and developing relevant technology. .The budget was approved for the use of building R&D infrastructure responding against novel infectious diseases like COVID-19 .The government has cleared a budget of 5.2 billion won to continue projecting severity of prognosis and developing treatment through analyzing clinical data from confirmed COVID-19 cases .5.8 billion won was approved to operate antiviral pharmaceutical test lab, while the budget for operating public vaccine development and support center has been expanded from 5 billion won to 13.6 billion won .Also, a budget of 3.3 billion won was given to constructing facility and laboratory infrastructure for the National Infectious Disease Research Institute .◆Preparing for the future health and welfare—fostering K-Bio: MOHW has decided to expand R&D and financial investment on infectious disease, regenerative medicine, data, and new drug .The ministry’s major healthcare R&D budget plan allocated 791.2 billion won for next year, increasing 49.9 percent compared to 527.8 billion won in 2019 .Innovative new drug R&D support would be also provided to nurture Korean-made new drug development .15.1 billion won would be injected to push state-led new drug development, covering candidate medicine discovery to commercialization .Meanwhile, 3.3 billion won would be assigned to state-led new anticancer treatment development .The ministry budgeted 6.8 billion won on training specialists on bioprocessing and AI-basis new drug development and clinical trial .More specifically, 3 billion won on training Korean National Institute for Bioprocessing Research and Training (NIBRT) consultant and instructor, 2.1 billion won on biopharmaceutical specialists, 1 billion won on training and promoting AI-basis new drug development and 700 million won were drawn up for the budget .A separate budget plan for promoting regenerative medicine, backed by the Advanced Bio Act, was set .From basic science research like induced pluripotent stem cell (iPSC) technology for regenerative medicine to developing advanced biopharmaceuticals, rare disease treatment clinical research and relevant R&D would be operated according to the new legislation .Particularly for the regenerative medicine R&D, a budget of 10 billion won on regenerative medicine clinical study, and 6.4 billion won on pan-government regenerative medicine R&D program were set .A big data platform would be built to incorporate public institute data, genome and medical data for the technological innovation in biohealth .And 60.2 billion won would be spent on pan-government medical device R&D program covering from R&D to clinical trial, approval and commercialization .A budget of 5.3 billion won was set for healthcare professionals to conduct clinical evaluation and receive training to use Korean-made medical devices .◆Expanding public medicine: MOHW expanded the state funding for the support on improving medical safety net through NHI coverage enhancement .The publicness of regional medical center would be strengthened as well .The government plans to enhance the infectious disease response capacity of regional medical centers and to expand regional healthcare institutes (from 12 to 15), and provincial healthcare institutes (from 15 to 35) .Also, some of the budget was allocated for the preventive healthcare program, or so-called ‘Korean New Deal.’ As a pilot program, MOHW would expand healthcare centers subject for preventive healthcare program through ICT devices (Bluetooth blood pressure monitor, and blood glucose monitor) currently set as 30 to 80 sites .The healthcare center’s customized healthcare support program via mobile app for high-risk patients with chronic disease would incorporate 160 sites with 20 more sites than this year .Additional human resources for the program would be dispatched as well .◆The Inclusive State—healthcare reimbursement: The government plans to increase the overall NHI reimbursement per beneficiary, currently set at 6.50 trillion won, to 7.23 trillion won with 11.2 percent increase .And by cooperating with NHI, the ministry would continue to enhance healthcare coverage .
- Company
- Sales of immunotherapy for Cancer are ↑18 times in 4 years
- by An, Kyung-Jin Sep 02, 2020 06:19am
- (Clockwise from top left) Yervoy, Opdivo, Keytruda,Imfinzi,& Tecentriq Immunotherapy for Cancer is expanding rapidly in the domestic pharmaceutical market. The domestic immune checkpoint inhibitor market started with Yervoy (Ipilimumab), Keytruda (Pembrolizumab), and Opdivo (Nivolumab), and generics such as Tecentriq (Atezolizumab) and Imfinzi (Durvalumab) were added one after another, sales increased by 18 times over the past four years. MSD's Keytruda, which took the lead in the lung cancer treatments, occupied 60% of the total market, showing its influence, and Roche's Ticentric' & AstraZeneca’s Imfinzi are on the rise. According to IQVIA, a drug market research institute on the 1st, sales of five types of Immunotherapy for Cancer in the first half of this year was a joint venture of ₩126.7 billion. This is a 31.7% increase from ₩96.1 billion in the first half of last year. It increased by 17.5 times from ₩7.2 billion four years ago. Immuno-anticancer agents are monoclonal antibodies that induce T cell activation by blocking inhibitory signals from T cells involved in immune regulation in the body. Unlike chemotherapy or targeted anticancer drugs, they are also called third-generation anticancer drugs in that they treat cancer by activating the body's immune system. There are various types of immune anticancer agents, but immune checkpoint inhibitors that treat cancer by activating immune function by suppressing the immune checkpoint, which is a pathway through which cancer cells evade immune cells, are collectively referred to as immune anticancer drugs. In Korea, BMS and Ono Pharmaceutical's immune anti-cancer drug Yervoy was approved in December 2014 as the primary treatment for melanoma patients who could not operate or have metastasized, Yervoy is the first immune checkpoint inhibitor that acts on the CTLA-4 protein on the surface of immune cells. In 2015, immune checkpoint inhibitors with mechanisms that inhibit PD-1 protein, such as Keytruda of MSD and Opdivo of BMS, were released and the market scale was in earnest. Since then, competition is accelerating with the launch of Roche's Tecentriq in 2017, AstraZeneca's Imfinzi in 2018, and Merck·Pfizer's Bavencio in 2019. Quarterly sales trend of five major immune checkpoint inhibitors (Unit: ₩ million, Source: IQVIA) Currently, Keytruda has taken the lead in the market. The sales of Keytruda in the first half of this year were totaled at ₩72.3 billion. It is 26.4% higher than ₩57.2 billion in the first half of last year, leading overall drug sales. Of the five immune checkpoint inhibitors, the proportion of Keytruda accounted for close to 57.1%. Keytruda inhibits the 'PD-1' protein on the surface of T cells to prevent binding to the PD-L1 receptor and acts as a mechanism to activate T cells. Following the first indication, melanoma, it has shown excellent efficacy in over 30 carcinomas such as lung cancer, head and neck cancer, gastric cancer, and cervical cancer, showing overwhelming results worldwide. Last year, it surpassed ₩10 trillion in global sales, ranking second in sales following Humira (Adalimumab), and It is observed that it will rise to the top in global sales by 2026. In Korea, because of its high price, the quarterly sales of Keytruda remained around ₩3 billion, but the application of health insurance benefits for secondary treatments for non-small cell lung cancer in August 2017 acted as a catalyst for sales growth. Keytruda sales exceeded ₩10 billion in the first quarter of 2018, and quarterly sales of ₩30 billion have been recorded since the second quarter of last year. In the first quarter of this year, it lowered Lipitor (Atorvastatin) and rose to the top in domestic pharmaceutical sales, and continued to lead for two consecutive quarters. If the reimbursement is expanded, the sales volume is expected to increase even more. However, there is a difference between the sales aggregate of Keytruda and the sales that the company actually secures according to the risk-sharing contract (RSA) of the refund type·expenditure cap signed with the government at the time of listing. Opdivo, which was once pointed as the biggest rival of Keytruda, widened the gap with sales of ₩30.6 billion in the first half of this year. Opdivo lost its leadership to Keytruda after clinical failure related to primary lung cancer treatment in 2017. In Korea, after setting a new record for quarterly sales of ₩17.2 billion in the fourth quarter of 2018, the trend continues to decline. As of the first half of this year, the share of the five immune checkpoint inhibitors accounted for 24.2% of sales. Opdivo is evaluated as having missed the market leadership because it failed to preoccupy it as a primary treatment indication for non-squamous non-small cell lung cancer showing positive PD-L1 findings. Non-small cell lung cancer accounts for about 80% of all lung cancers. About 25-30% of them are classified as squamous non-small cell lung cancer. Market share of 5 immune checkpoint inhibitors in the first half of 2020 (Unit: %, Source: IQVIA) Except for Keytruda and Opdivo, the influence of other items in the immune checkpoint inhibitor market is still insignificant. In the first half of this year, Yervoy's sales were ₩700 million, similar to the same period last year. Yervoy was first released in Korea, but it has not exceeded ₩2 billion in annual sales. Although it is trying to rebound in sales by adding indications for combination with other treatments such as Opdivo, its application range is limited compared to other PD-1 and PD-L1 inhibitors. The quarterly sales of Roche's Tecentriq and AstraZeneca's Imfinzi are rapidly increasing since their domestic release. Tecentriq recorded ₩15 billion in sales in the first half of last year, more than four times higher than ₩3.7 billion in the first half of last year, making it the third largest of the five immune checkpoint inhibitors. The market share rose to 11.8%. Imfinzi, which started generating sales in the first half of last year, recorded sales of ₩8.1 billion in the first half of this year. Five kinds of immune checkpoint inhibitors are trying to expand their indications based on continuous clinical research. Bavencio recently concluded a drug price negotiation with the NHIS, and the application of insurance benefits is imminent. For the time being, the domestic immune checkpoint inhibitor market is expected to continue high growth.
- Company
- AZ Korea Director Chon as a new Country President Indonesia
- by Eo, Yun-Ho Sep 02, 2020 06:18am
- Chon Sewhan, a director at AstraZeneca Korea, has been promoted as a Country President at PT. AstraZeneca Indonesia The industry sources reported the current Cardiovascular, Renal and Metabolic Diseases (CVRM) Business Unit Director, Chon Sewhan, has been appointed as a Country President Indonesia as of Sept. 1. Started off his career as an accountant, Director Chon was an acting-Country President Korea, until the current Country President Kim “Juno” Sangpyo was appointed after former Country President Liz Chatwin has been transferred back to the Australian and New Zealand office in September 2017. After graduating from Korea University, he earned his MBA from University of Pennsylvania the Wharton School and worked at a global accounting consulting group, PWC. He stepped into the pharmaceutical industry as a financial manager at Abbott Korea, and gained his experience in finance, R&D and business development from Novartis Headquarters, the U.S. branch and AstraZeneca Korea. In 2018, Chon was appointed as CVRM Business Unit Director at AstraZeneca Korea. The global company has yet to decide his successor. And due to COVID-19, the new Country President Indonesia would be remotely working from South Korea for a while.
- Policy
- HIRA clears all Strensiq pre-approvals from July
- by Lee, Hye-Kyung Sep 02, 2020 06:18am
- Handok’s rare disease treatment Strensiq injection (asfotase alfa) passed the preliminary approval review and processed the first reimbursed administration. Listed for healthcare reimbursement as of June 1, Strensiq is a third drug to be required to receive pre-administration approval for a reimbursed use of the drug. Soliris injection (eculizumab) and Spinraza (nusinersen) are the other drugs required to pass the pre-approval. . Health Insurance Review and Assessment Service (HIRA) Healthcare Review and Assessment Committee has approved of granting reimbursement on two cases that applied in July .Strensiq’s maximum pricings for all doses are set at 806,964 won (12 mg), 1,210,446 won (18 mg), 1,882,916 won (28 mg), 2,689,880 won (40 mg), and 5,379,760 won (80 mg) .Handok has signed the Korean market sales right deal over Strensiq with the U.S.-based company, Alexion on Nov .17, 2016 to strengthen their strategic partnership first made through Soliris .Strensiq is indicated as an enzyme replacement therapy treating bone related symptoms in patients with infantile-onset hypophosphatasia (HPP) .A patient with infantile-onset HPP would receive coverage when qualifying all following conditions—level of alkaline phosphatase (ALP) measures lower than normal range of the certain age and sex group but exceeds normal range of Pyridoxal-5’-phosphate (PLP); bone condition unique to HPP confirmed through radiograph prior to treatment; initial treatment received before the age of 19 .A clinical evaluation (height, weight, reparatory function, motor development stage, ambulatory function and pain) has to be conducted prior to the initial treatment, three and six months into the therapy, and every six months from then on .The pre-approvals were respectively deliberated on male children aged four and six .The four-year-old was diagnosed with HPP eight days after the birth, and started using Strensiq from the first month (June 2016) .The six-year-old was diagnosed with the same disease at 11-month-old and started administering the injection from 21st month (January 2016) .These patients were provided with the coverage on the continuous treatment as their clinical evaluation, blood test and radiological report after the administration improved, and they did not reach the administration suspension standards . Meanwhile, two out of three reimbursed administration applications on spinal muscular atrophy (SMA) treatment Spinraza were approved from last month .The health authority requested additional supplementary data .The 28 administration monitoring reports were all cleared . For this time, Soliris did not have anyone requesting for new administration in a patient with paroxysmal nocturnal hemoglobinuria (PNH), but only three out of six new applications on treating atypical hemolytic uremic syndrome (aHUS) have been cleared .The other three have been denied .
- Company
- Forxiga by AstraZeneca appeals against Dong-A ST
- by Kim, Jin-Gu Sep 02, 2020 06:18am
- ForxigaAstraZeneca, which failed in the first round of the patent dispute over the SGLT-2 inhibitor-based diabetes treatment, Forxiga (Dapagliflozin), launched a counterattack against Dong-A ST. It disagrees with the trial decision of the Patent Tribunal, who sided with the generic company, and filed a lawsuit to the Patent Court of Korea to cancel the trial. As AstraZeneca led the patent dispute to the second trial, the 'Pro-drug' method of patent avoidance strategy brought up by Dong-A ST was also put to the test. In the pharmaceutical industry, The pharmaceutical industry is paying attention to the patent court's ruling on whether a new patent strategy that came out long ago can continue. According to the pharmaceutical industry on the 31st, AstraZeneca filed a lawsuit against Dong-A ST to cancel the trial decision in the Patent Court of Korea on the 28th. The intention is that the trial decision made by the Intecllectial Property Trial and Appeal Board is unfair. On June 23, the Board sided with Dong-A ST in a trial to confirm the passive scope of rights filed by Forxiga on a material patent. This decision received great attention from the pharmaceutical industry. This is because many pharmaceutical companies have challenged Forxiga’s material patent, but only Dong-A ST has succeeded in avoiding it. It is explained that there was a technology called 'pro drug' behind Dong-A ST's ability to overcome the patent. Chemical structure of DapagliflozinProdrugs are a different strategy, seemingly like salt-modifying drugs. It is a kind of incrementally modified drugs. It is a way to improve a little differently from the original by changing the substituent of the substance. However, the difference between the salt and the substituent is large. The chemical structure of the substance itself does not change. The chemical structure of the prodrug is partially changed. There is also a big difference in technology. it can be changed by simple ionic bonding. In the case of prodrugs, the substituents must be changed in a more tricky way, called a covalent bond. The likelihood of success is also lower. The salt change strategy adopted by many generic companies in the past has become impossible due to the so-called 'Solifenacin ruling' in January of last year. The Intecllectial Property Trial and Appeal Board (1st trial) regarded the prodrug as a new one different from the original ingredient. On the other hand, AstraZeneca believes that the product being developed by Dong-A ST exhibits the same pharmacokinetics in the body as Dapagliflozin, and is converted into Dapagliflozin to exert an effect, so it is believed to be infringing Forxiga's material patent. Accordingly, AstraZeneca said that it will reaffirm the scope of the rights of material patents and protect Forxiga's intellectual property rights. Sang-pyo Kim, CEO of AstraZeneca Korea said, "Material patent for Dapagliflozin is the result of research and development with a lot of effort and cost, and such excellent patent technology is respected until the expiration date." Forxiga has two material patents. One expires on April 7, 2023, and the other expires on January 8, 2024. Among them, the patent invalidation lawsuit that expires in 2024 won the first trial by generics, and the second trial is currently underway. Dong-A ST is the only one that has avoided both patents. Dong-A ST is expected to be released in the second half of next year as soon as it has undergone clinical and approval. If it goes as planned, it means that it will be possible to release the generic nine months ahead of other companies.
- Company
- Indication of Alunbrig expanded as ALK-positive lung cancer
- by Sep 02, 2020 06:18am
- The indication has been expanded as the first line treatment of Takeda Pharmaceutical Korea's lung cancer treatment, Alunbrig. Takeda Pharmaceutical Korea (CEO Moon Hee-seok) announced on the 28th that The MFDS approved Alunbriq (Brigatinib), an anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer drug, to expand its indication as a first-line treatment for ALK-positive advanced or metastatic non-small cell lung cancer on the 27th. Alunbrig has been used in the treatment of ALK-positive advanced or metastatic non-small cell lung cancer, which has been treated with Crizotinib in April of last year under insurance coverage. With the expansion of this indication, Alunbrig can also be used in patients with ALK-positive non-small cell lung cancer who have not been treated with existing primary ALK inhibitors. The approval was based on a second interim analysis of the ALTA-1L clinical trial in 275 patients with ALK-positive locally advanced or metastatic non-small cell lung cancer who had not previously been treated with ALK inhibitors. Patients enrolled in the ALTA-1L clinical trial were randomly assigned to the Alunbrig group and the Crizotinib group according to the brain metastasis and past chemotherapy at baseline. The primary endpoint is the progression-free survival (PFS) evaluated by the Blinded Independent Review Committee (BIRC), and the secondary endpoint is the objective response rate (ORR) evaluated by the BIRC, the intracranial objective response rate (intracranial ORR), intracranial PFS and overall survival (OS). As a result of the second interim analysis conducted based on the progress up to June in 2019, it was confirmed that patients receiving Alunbrig improved the risk of disease progression or death by about 51% compared to the crizotinib group. (HR, 0.49; 95% CI, 0.35-0.68; log-rank P
