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- 2026-05-15 22:34:46
- Policy
- Follow-up of impurity inspection
- by Lee, Hye-Kyung Jul 01, 2022 05:49am
- The MFDS received the results of testing and testing of Nitrosamine impurities from domestic pharmaceutical companies, and prepared safety management guidelines as a follow-up measure. This guideline is for safety management of N-Nitrosamines, a mutagenic and carcinogenic impurity among drugs, and it should be implemented by raw and finished drug manufacturers and importers to reduce or prevent impurities within the daily intake allowance. Starting with high blood pressure medicine (Valsartan) in 2018, tuberculosis medicine (Rifampicin) in 2021 as Nitrosamines were detected in drugs every year until Rifampicin), and new mutagenic impurities were recently detected, the MFDS received a test report of the company's own test on the evaluation items that may occur until the 31st of last month. The MFDS will continue to review impurities that may be included in medicines through close cooperation with overseas regulators and recommend appropriate measures to related pharmaceutical companies. According to the guidelines, apart from the MFDS' review of impurities, pharmaceutical companies should closely examine the raw material drug synthesis process and the manufacturing process of finished drugs using currently available science and technology to evaluate the potential cause and possibility of impurity generation. Pharmaceutical companies should check all impurities that may occur in the process of synthesizing and storing raw materials, manufacturing and storing finished drugs, evaluate the mutagenicity of the impurities, and if mutagenicity or carcinogenicity is confirmed, the risk of carcinogenesis is less than 1/100,000. (Q)SAR methods can be used to predict bacterial mutagenicity test results using a computer, appropriate management methods can be applied based on structural warnings, or bacterial mutagenicity tests can be conducted directly for specific impurities Nitrosamines impurities are compounds with potential carcinogenicity or mutagenicity that can occur mainly when they are combined under conditions where Amine and Nitrosating agent can react. The causes of Nitrosamines impurities in drugs identified so far can be classified as risk factors related to the manufacture and storage of raw and finished drugs, and there are also risk factors related to GMP. When detecting impurities, pharmaceutical companies should report data on the possibility of occurrence to the MFDS, the cause of occurrence (including the estimated cause), the detection amount, and the daily intake allowance. According to the step-by-step measures prepared and distributed by the MFDS, pharmaceutical companies should compare the amount of impurity detection and acceptance criteria, take necessary measures such as voluntary recovery and reduction of impurities in the market, and submit related matters to the MFDS. It will review necessary measures based on information collected from pharmaceutical companies' reporting of impurity detection and overseas regulatory agencies. If it is deemed necessary for the safety management of drugs in circulation in Korea, it is planned to instruct to evaluate the possibility of impurities and conduct test tests on specific drugs.
- Policy
- Opdivo succeeded in setting the standard as the first treatm
- by Lee, Tak-Sun Jul 01, 2022 05:49am
- Ono's Opdivo succeeded in setting the benefit standard as the first treatment for gastric cancer for the first time as an immuno-cancer drug. The HIRA held its sixth meeting in 2022 on the 29th and set the standard for the efficacy of Opdivo's primary treatment for gastric cancer. This is the first time that immuno-cancer drugs have passed the deliberation committee as the first treatment for gastric cancer patients. The deliberation committee established a combination of Opdivo's Fluorouracil system and platinum-based chemotherapy as the primary treatment for progressive or metastatic gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma. However, the standard was not established for combination therapy with Ipilimumab as the primary treatment in adult patients with dermatoma among malignant pleural patients who cannot be operated, which is another indication of Opdivo. On this day, Celgene's Revlimid also succeeded in setting the benefit standard for maintenance therapy for patients who received newly diagnosed autologous hematopoietic stem cell transplants among multiple myeloma. Imbruvica and Glivec Film Coated Tab, which started to expand the benefit standard, failed to set the standard. Janssen's Rybrevant and BMS Korea's Inrebic, which newly applied for benefits, failed to set the standards, making it necessary to try again.
- Policy
- SKY Covione is promoted the registration of the WHO EUL
- by Lee, Hye-Kyung Jul 01, 2022 05:49am
- SKY Covione, a COVID-19 vaccine developed in Korea and approved, is conducting a rolling review to promote the registration of the WHO Emergency Use List (EUL) and to go through the European EMA approval process. The MFDS (Director Oh Yoo-kyung) held a briefing at 2 p.m. today (29th) and announced that it decided to approve the product on June 29th on the condition that SK Bioscience submitted a final clinical trial report for COVID-19 vaccine SKY Covione. At the briefing, Park In-sook, head of the bio-drug review department at the National Institute of Food and Drug Safety Evaluation, explained the future commercialization schedule of SKY Covione, where item permission was granted. Director Park said, "Even if the vaccine is already approved, the quality will be tested once more in the country before each developer ships it. If SK Bioscience applies for approval for shipment in Korea at the time of shipment of SKY Covione, the MFDS will conduct a quality test and use it according to the health authorities' vaccination plan." Regarding overseas use, Director Park said, "It will be used a lot in other countries only when the WHO's approval is made," adding, "SK Bioscience has submitted an application to the WHO and the EMA is also preparing a pre-rolling review to get permission." Although the first COVID-19 vaccine in Korea has been released, pharmaceutical companies that are currently conducting clinical trials to develop the COVID-19 vaccine are also appearing one after another. Director Park said, "Since most of the basic vaccinations are in place in Korea, pharmaceutical companies are changing their strategies rather than stopping the development of vaccines themselves." He said, "We are preparing for development before additional vaccinations, not basic vaccinations, and the MFDS also held two meetings with developers to prepare guides for the development of additional vaccinations. Guidelines will come out soon," he said. At the briefing, Oh Yoo-kyung, head of the MFDS, said, "SKY Covione is the first domestic COVID-19 vaccine approved by the MFDS." In other words, the clinical trial plan was quickly approved by forming a permission review team to apply a customized pre-consultation system for each non-clinical, clinical, and quality stage, and introduced an immunogenic comparative clinical trial method to expedite a large-scale clinical trial. The MFDS said it has approved SKY Covione for the first time in the world with the same licensing requirements and screening criteria as advanced countries such as the United States and Europe, and has established a test method necessary for vaccine testing at the same time. Director Oh said, "With this permission, Korean companies' ability to develop COVID-19 vaccines has been proven internationally." She emphasized, "We can expect to enter the global vaccine market in the future."
- Product
- “Need to raise awareness and seek early diagnosis of Sjogre
- by Eo, Yun-Ho Jul 01, 2022 05:49am
- Dr. Ji Sun Lee “We can fully provide the standard of care at local rheumatoid clinics. Have trust and visit a local clinic near you.” If you are experiencing symptoms such as dry mouth, eyes, nose and mucous membrane, skin, or indigestion without underlying diseases or other medication histories for over 3 months but haven’t found its cause, it can be Sjogren's syndrome. Sjogren's syndrome is an autoimmune disorder whose cause has not been identified yet. Scientists believe it is a multifactorial disease that involves various factors such as genetics, hormone, virus or bacteria infection, nervous system, cytokines, and autoimmune antibodies. It is known to occur relatively more often in middle-aged women over the age of 40. According to National Health Insurance Service statistics, the number of patients who received treatment for Sjogren's syndrome in Korea had increased from 17,634 in 2015 to 21,282 in 2019. 2019 statistics show that its incidence was 7.7 times higher in women than men, and 83% of the patients were women over 40 years of age. Despite the inconveniences felt by the patients and its rarity, Sjogren's syndrome is not as dangerous as it seems. This is why doctors emphasize the need for accurate, prompt diagnosis and treatment. Ji Sun Lee (43), Director of the RheumaEZ Clinic in Busan, Korea, said, “It is not a disease of serious concern from the doctor’s point of view. Although it is an autoimmune disorder, using an immunomodulator may be excessive. There is no fundamental cure, but its symptoms can be alleviated through continuous medication and lifestyle management.” Lifestyle modification is very important to control dryness. Patients with Sjogren's syndrome need to drink water often to keep the mouth moist. Chewing sugarless gum can help boost saliva production. Patients should avoid highly caffeinated drinks such as coffee, black tea, and green tea, as they promote the diuretic effect and aggravate dry mouth. However, as Sjogren's syndrome is an unfamiliar condition, it takes some time for patients to be confirmed after symptom onset. Lee said, “Such delays in diagnosis result in unfortunate cases where patients are unable to see any effect from treatment due to their worsened condition. These days, there are genetic tests available to preemptively check the risk of typical eye diseases including Sjogren's syndrome before onset" Lee added “If you have severe dryness in mouth and eyes for more than 3 months and experience frequent swelling and pain in your salivary gland area under the ears, please visit a rheumatologist near you for diagnosis. Sjogren's syndrome is nowadays better recognized at general internal medicine clinics, and therefore is well it is recommended to visit the rheumatologist for diagnosis." Fortunately, Sjogren's syndrome is better recognized in general internal medicine recently and is being better referred these days.” Sjogren's syndrome is also well covered insurance-wise. With the application of the special calculation system, the co-insurance rate borne by the patient is around 10%. Lee said, “Although not a severe disease, Sjogren's syndrome does have a considerable impact on the quality of life of affected patients. Many experience insomnia and even depression. Therefore, the condition needs to be better managed by improving disease awareness and establishing an environment for its rapid diagnosis.”
- Company
- Tdap vaccine Adacel can be prescribed in general hospitals
- by Eo, Yun-Ho Jun 30, 2022 05:53am
- Sanofi Pasteur's new Tdap vaccine Adacel can be prescribed in general hospitals. According to related industries, the Tdap vaccine for teenagers and adults aged 11 or older has passed the DC of 100 medical institutions, including Seoul National University Hospital, Korea University Guro Hospital, Gangbuk Samsung Hospital, and Hallym University Gangnam Sacred Heart Hospital. As GSK's supply of Boostrix was suspended last year, additional prescriptions have recently been carried out rapidly. Adacel is a booster vaccine against pertussis by adding five preventive ingredients for pertussis to the existing Td vaccine that prevents diphtheria and tetanus. Re-vaccination of the DTap vaccine is recommended 5 years after the last Td vaccine, and it was found that the local side effects did not increase even if Adacel was vaccinated 2 years after the last Td vaccine. DTap vaccine is recommended to be vaccinated five times from 2 months old to 4 to 6 years old, and after that, it is recommended to be vaccinated once every 10 years from the age of 11 to 12. The number of cases of pertussis has increased since the 2000s in developed countries with high vaccination rates, increasing the need for additional vaccinations. According to U.S. CDC data, 75% of pertussis, especially in newborns, is known to be transmitted through family members, including parents. GSK announced at the end of last year that the supply of vaccines such as Rotarix, Cervarix, Synflorix, Menveo, Havrix, Priorix (MMR vaccine), Boostrix (Tdap vaccine), Infanrix-IPV, IPV/Hib (DTaP vaccine) was suspended. It is known that there was a document error in CTD. GSK added that it would resume shipping after submitting supplementary documents to the MFDS as it was a document error, not a quality issue.
- Company
- 16 companies including Amgen launch industrial union
- by Eo, Yun-Ho Jun 30, 2022 05:52am
- A new confederation of unions centered around multinational pharmaceutical companies is soon to be launched in Korea. According to industry sources, a National Pharmaceutical & Bio Labor Union (NPU) under the Federation of Korean Trade Unions will be launched on July 5th. Labor unions of 16 companies, including labor unions from Korean subsidiaries of MNCs like Novo Nordisk, Bayer, Amgen, Novartis, Viatris, Janssen, Pfizer (will transition to industrial union), and those of Sanofi-Aventis, Alvogen, Opella Healthcare, Merck, Boehringer Ingelheim, AstraZeneca, GSK, and Hyundai Pharm will become affiliated with NPU. According to NPU, many multinational pharmaceutical companies are actively planning company restructurings that include layoffs despite preserving their continuous sales growth in the COVID-19 crisis, and the domestic pharma-bio industry has also been going against the market growth and is deteriorating the working condition of its workers. Therefore, the NPU plans to actively engage in ongoing disputes of member unions while strongly responding to the restructuring that is expected in some companies. Deok-Hwan Ahn, Chairman of NPU, said, “We will work to set a standard for the wages and welfare of workers in the pharmaceutical and bio-industry and work in solidarity to respond to common issues that arise in the industry to guide the direction of our industrial union" The launch ceremony for the new industrial union will be held from 11:00 a.m. on July 5th, in the 6th-floor main conference room of the Federation of Korean Trade Unions Building. Meanwhile, many labor unions from Korean subsidiaries of multinational pharmaceutical companies that have left the Korea Democratic Pharmaceutical Union, the representative industrial labor union of multinational pharmaceutical companies, have joined NPU.
- Company
- 2nd P-CAB Fexclu to be released into the 800 bil market
- by Chon, Seung-Hyun Jun 30, 2022 05:52am
- Daewoong Pharmaceutical’s new drug, ‘Fexclu’ will be released next month. The industry’s eyes are on whether the drug will raise a storm in the PPI class and P-CAB class antiulcer medication prescription market that is estimated to be worth over ₩800 billion. The industry is also eyeing competition between Fexclu and K-CAB abroad. ◆Fexclu to be applied reimbursement from next month… prepares to target the ₩800 billion PPI·P-CAB market According to industry sources on the 29th, Daewoong Pharmaceutical’s Fexclu will be listed for NHI reimbursement starting next month. With the reimbursement approval, the drug will be released in the market 6 months after it received approval on December 30th. Fexclu’s insurance price cap was set at ₩939, which is 27.8% cheaper than its same-class drug K-CAB (₩1,300) Fexclu is a P-CAB class drug that treats gastroesophageal reflux disease (GERD). The drug was approved for the indication of treating erosive gastroesophageal reflux disease (GERD). P-CAB class antiulcer drugs competitively bind to the proton pump and potassium ion located in the final stage of acid secretion from the stomach wall to inhibit gastric acid secretion. This class of drugs has quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018. Fexclu will be mainly targeting the PPI class and P-CAB class antiulcer drug market, which raised ₩842.1 billion in prescriptions last year. The PPI class market made ₩732.5 billion and the P-CAB class market ₩109.6 billion last year. The industry sees a high possibility of Fexclu’s success in the market. K-CAB had already demonstrated the marketability of P-CAB class anticancer drugs during the past 3 years. According to UBIST, K-CAB had raised ₩109.6 billion in outpatient prescriptions 3 years into its release last year, which is the first time a single brand of a homegrown novel drug had made annual prescriptions exceeding ₩100 billion. K-CAB had created a sensation selling ₩30.9 billion in the first year of its release and has continued its rapid growth in 2020 and last year. K-CAB’s sales continued to grow due to its advantages - having a faster onset of action than PPIs, is allowed to be taken regardless of meal ingestion, demonstrating superior symptom improvement, and showing longer-lasting night-time gastric acid suppression. With HCPs and patients in the field already showing high satisfaction with P-CAB class antiulcer medications using K-CAB, Fexclu is expected to make a relatively easier way into the market. Also, Fexclu’s insurance cap, which was set 30% lower than that of K-CAB may act as an advantage in the prescription market. However, K-CAB owns a total of 4 indications, rendering it difficult for Fesclu to completely replace K-CAB in the market. In addition to the treatment for erosive and non-erosive GERD, K-CAB sequentially secured additional indications as a combination therapy with an antibiotic for Helicobacter pylori eradication in patients with peptic ulcer or chronic atrophic gastritis. Among the indications, insurance reimbursement is applied to K-CAB for the treatment of GERD and stomach ulcers. Fexclu will also be targeting PPI-class drugs that account for the largest amount of the antiulcer drug market, as a significant amount of K-CAB prescriptions arise from patients who have switched to K-CAB from PPIs. Last year, the amount of outpatient prescriptions for PPI class drugs recorded ₩732.5 billion. This is a twofold increase in 5 years from the ₩372.4 billion in 2016 and is continuing to record high growth. ◆Fexclu·K-CAB accelerates entry to overseas market… competition in overseas performance of the two drugs also a point of interest The overseas market competition between Fexclu and K-CAB is also a point of interest. Daewoong Pharmaceuticals had signed 6 export agreements with 15 countries in North America, Latin America, China, Middle East to export Fexclu. In 2020, the company signed a contract with the Mexican pharmaceutical company Moksha8 and Brazil's EMS for the local marketing and sales rights of Fexclu and paved the way for Fexclu’s entry into Central and South America. In March last year, the company signed a $384.5 billion contract with China's Shanghai Haini Pharmaceutical. Status of Fexclu export agreements (Source: Daewoong Pharmaceutical)) In June last year, the company made a technology transfer agreement with U.S. company Neurogastrx and handed over the development, authorization, and sales rights of Fexclu in the US and Canada. Through the agreement, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront, non-refundable fee, and was assured up to $430 million in development, regulatory, and sales milestone payments. It then signed 2 additional export contracts to enter 10 countries in Central and South America and the Middle East. In total, Daewoong secured up to ₩1.2 trillion through export agreements for Fexclu. K-CAB has entered the market of a total of 34 countries through technology or finished product exports. HK Inno.N had first signed a technology export agreement with the Chinese company Shandong Luoxin Pharmaceutical in 2015. The deal was to receive $18.5 million in upfront payments and clinical development, regulatory, and sales milestone payments. The company estimated that the agreement amount would rise to $95.29 million with royalties incurred after the local commercialization of K-CAB. Also, HK InnoN signed an export agreement for the finished K-CAB product with the Mexican pharmaceutical company Laboratorios Carnot in February 2019 to export K-CAB to 17 countries in Central and South America. Its export amount, including supply price, has amounted to $84 million over the past decade. Exports agreements have been more actively made after K-CAB was released in Korea. In September 2019, contracts were signed to supply the finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export agreements were made to export K-CAB to Mongolia and Singapore. Last year, the company also signed export contracts with companies in Vietnam, Malaysia, the US, and Canada.
- Policy
- SK Bioscience gets final approval for SKYCovione
- by Lee, Hye-Kyung Jun 30, 2022 05:52am
- Permission for the item COVID-19 Vaccine No. 1 developed and manufactured in Korea is imminent. As a result of discussing SKYCovione's safety and effectiveness, the Central Pharmaceutical Review Committee said that it was recognized for the purpose of preventing COVID-19 based on the immunogenic clinical results compared to Vaxzevria, which was already approved, and that the item could be approved. The MFDS (Director Oh Yoo-kyung) explained the progress of item approval for the COVID-19 vaccine SKYCovione (GBP510) developed and manufactured by SK Bioscience in Korea at 10 a.m. on the 27th. SK Bioscience applied for a preliminary review of quality data on April 15, and an application for item permission was received on April 29. A meeting of the Central Pharmaceutical Affairs Review Committee was held at 4 p.m. on the 26th to advise on the safety and effectiveness of SKYCovione. Based on the submitted data such as clinical trial data for SKYCovione, the committee acknowledged the safety and effectiveness of the drug and discussed whether the item permission was appropriate. In particular, experts' comprehensive opinions were exchanged on overall permits, such as overall views on the effectiveness and safety of vaccines and measures to secure safety after approval. As a result of discussing whether SKYCovione's safety and effectiveness were recognized, safety such as abnormal cases that occurred in clinical trials was judged to be acceptable. However, there was an opinion that the predicted adverse reactions in the local and systemic areas were more likely to be caused by vaccinations such as fatigue, muscle pain, headache, chills, fever, joint pain, nausea, vomiting, and diarrhea in adults younger than the first dose. Unforeseen adverse events related to vaccine administration (4 weeks after administration) occurred in about 13.3% (402/3029 patients) of the vaccine group, the main symptoms were injection site hyperplasia, dizziness, pain, etc., and the control group was about 14.6% (145/996). The serious abnormalities were similar to 0.5% (15 cases, 15 cases) in the vaccine group and 0.5% (5 cases, 9 cases) in the control group, and there was 1 rapid progressive glomerulonephritis, which cannot be excluded from vaccine administration, but it was recovering at the time of submission of clinical trial data. In the immunogenicity results comparing already approved Vaxzevria with a control vaccine, neutralization antibodies formed 2.93 times after 14 days of administration every four weeks over the age of 18, and serum conversion rate was 98.06% in the vaccine group and 87.30% in the control group. It was suggested that the overall safety security plan is appropriate, and it is reasonable to observe and evaluate abnormal cases of special interest similar to existing vaccines as a risk management plan after approval. The Ministry of Food and Drug Safety said, "When compiling the opinions of the committee, it was agreed that SKYCovione could be approved." The MFDS received advice from the COVID-19 treatment, vaccine safety, and effectiveness verification advisory group on June 21 to enhance the expertise and objectivity of the COVID-19 vaccine licensing review process. The effectiveness for permission is recognizable, and safety during clinical trials is acceptable, and abnormal cases of special interest should be observed and information should be collected after permission. The MFDS will review SKYCovione's submission data, comprehensively judge expert opinions, efficacy, effectiveness, dosage, and recommendations obtained from the advice of the COVID-19 vaccine safety and effectiveness committee, and hold a final inspection committee to make a final decision.
- Opinion
- [Reporter's view] Negotiation of Zolgensma
- by Jun 30, 2022 05:52am
- Attention is focused on negotiating the drug price of Zolgensma, a one-shot treatment and the most expensive drug in Korea. Conflicts are in full swing between the government to set the lowest price and pharmaceutical companies to be recognized as much as possible for new drugs. Zolgensma is a gene therapy approved in May last year. It is used for a severe and rare disease called SMA. This disease is causing muscles to gradually shrink. Based on the most serious type of SMN type 1, motor neurons are damaged more than 95% within six months of microtreatment, and 90% die before the age of two. Prior to Zolgensma, there were treatments for spinal muscular atrophy such as Spinraza and Evrysdi, but Zolgensma is special for patients. This is because unlike other treatments that require continuous medication, Zolgensma can fundamentally treat the disease with one dose. While existing treatments are involved in backup genes to increase SMN protein production, Zolgensma functionally replaces the deficient SMN1 gene so that protein can continue to be produced in one shot. The issue is the price of medicine. In the United States, the cost of administering Zolgensma amounts to about 2.5 billion won. Even in countries with low prices of Zolgensma, it is generally about1.9 billion won. There have been several drugs worth hundreds of millions of won so far, but Zolgensma is the first drug to exceed 2 billion won. Since Zolgensma is a single administration, the overall cost may be similar to other drugs that are multiple administrations. As ultra-high-priced drugs that need to be administered multiple times will continue to appear, it was time for the government to consider a new drug price model to be applied to ultra-high-priced drugs. As various discussions continued, Zolgensma was submitted to the HIRA about a year after applying for benefits through the patent linkage system and was recognized for its appropriateness. Earlier this month, it entered the drug price negotiation stage. The NHIS and Novartis Korea will hold two months of Zolgensma price negotiations until the 25th of next month. The government wants to set the price at the lowest level among major OECD countries. The standard that the government has in mind is known to be lower than 1.9 billion won in Japan. Pharmaceutical companies want to be recognized for the value of new drugs as much as possible. If negotiations are slow, it is the patients who are frustrated. Earlier this year, parents of SMA patients delivered their opinions to the National Assembly calling for Zolgensma. A parent who attended the meeting said, "My child has no muscles all over his body and can't eat anything with his mouth, so he lives on an oxygen respirator. Getting Zolgensma is only a hope. The longer the discussion, the more my child misses the golden time," he appealed. There are some people anxiously waiting for Zolgensma, which can be expected to be cured once administered. I hope that the two sides will not take the drug price negotiation extension for granted by only putting forward each other's positions, but will be determined to complete the negotiations within the deadline from the patient's point of view. After all, doesn't both the system and the new drug exist for patients?
- Company
- Opdivo reattempts reimb in first-line gastric cancer
- by Eo, Yun-Ho Jun 29, 2022 05:54am
- The cancer immunotherapy drug Opdivo is reattempting reimbursement as a first-line treatment once more. According to industry sources, Ono Pharma Korea and BMS Korea’s PD-1 inhibiting cancer immunotherapy Opdivo (nivolumab) will be deliberated by the Cancer Disease Deliberation Committee (CDDC) of the Health Insurance Review and Assessment Service on the 28th. In Korea, Opdivo was approved ‘as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma’ in June last year. With the added indication, the drug became the first and only domestically approved cancer immunotherapy for the first-line treatment of gastric cancer. Also, Opdivo’s unresectable malignant pleural mesothelioma indication will also be deliberated at the CDDC meeting. More specifically, Opdivo’s indications as ▲ first-line treatment of advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with chemotherapy, and ▲ in combination with ‘Yervoy’ in unresectable malignant pleural mesothelioma will be deliberated at the CDDC meeting. In the CDDC meeting that was previously held in February, the committee decided not to set reimbursement standards for both indications. Therefore, whether Opdivo’s second attempt at reimbursement in gastric cancer will bear fruit remains to be seen. Gastric cancer is considered to be the field in most urgent need of extended reimbursement to immunotherapy drugs after lung cancer. As the most prevalent cancer and the fourth most common cause of cancer deaths in Korea, gastric cancer has a favorable survival rate when detected in its early stages but its relative survival rate drops to 5.9% with distant metastasis. In particular, the current stand of care for HER2-negative gastric cancer is chemotherapy due to the unavailability of new drugs approved for first-line treatment for the past decade. Opdivo has received attention as a viable alternative for these patients. Meanwhile, Opdivo’s efficacy in lung cancer was confirmed through the large-scale Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive Opdivo compared to the 11.6 months in the control group. In PD-L1 positive patients (CPS ≥ 5), the Opdivo combination group’s mOS was 14.4 months, which was a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group in both the all-randomized population and PD-L1 positive patients.
