- LOGIN
- MemberShip
- 2025-12-25 15:34:14
- Company
- Bayer·Viatris·Pfizer settles in new locations
- by Eo, Yun-Ho Oct 18, 2021 05:54am
- News of multinational pharmaceutical companies’ relocations continue. According to industry sources, Korean subsidiaries of multinational pharmaceutical companies including Bayer, Viatris, and Pfizer have decided on their new offices and are working on relocation projects. Bayer Korea, which had been located in Boramae, Dongjak-Ku for a long period of time, will move to Yeouido next month (in November). Bayer’s new company building will be located in Yeoido’s hot place, Parc1 Tower. With the relocation, the company’s new headquarters will become a smart office with improved transport access, which was one of the disadvantages of the existing office building. Yeoido has risen as a strategic core in the pharmaceutical industry since 2018 when Novartis Korea has moved into the IFC building. With Bayer’s relocation, a total of 4 pharmaceutical companies – Bayer Korea, Biogen Korea, Alvogen Korea, and Novartis Korea – will be in Yeoido. Viatris Korea, a spinoff of Pfizer Korea, has confirmed its relocation to the Grand Central Tower near the Seoul Station earlier next year. Viatris had been using the shared office ‘FAST FIVE Myeong-dong’ as a temporary office from August until the end of this year. Viatris plans to actively reflect the various experiences it accumulated in the shared office to establish a smart working environment in the new headquarters so that employees can work at ease. At FAST FIVE Myeong-dong, employees were able to choose from the open space where they can perform individual tasks, one-person independent space for virtual meetings, and meeting space for 2-3 to 10 or more people, to meet the employee’s individual needs. After selling Myeongdong’s landmark Pfizer Tower at ₩112 billion, Pfizer opted to maintain its geographic legacy. The company sold its building to GRE Partners 15 months after the building was put on sale. After discussing various options, the company had decided on Namsan State Tower as its new home and plans to move in next year. The new office is located within a walking distance of the existing Pfizer Tower and will be moving into the new building in the second half of next year. Meanwhile, new Korean subsidies of multinational pharmaceutical companies are being established this year. The promising Chinese pharmaceutical company ‘BeiGene’ established a new subsidiary in Korea, and Moderna, one of the COVID-19 vaccine developers, has also registered its corporation and is awaiting launch in Korea.
- Company
- Rediscovery of Clopidogrel brings back generic boom
- by Kim, Jin-Gu Oct 15, 2021 05:57am
- Picture of Plavix, a clopidogrel original Development of generics using ‘clopidogrel,’ an antiplatelet drug, is regaining momentum. A company that already owned a clopidogrel generic has released a new dose product in 16 years. And the generic companies have been showing positive responses after the effect of clopidogrel was reilluminated in a study on stent-inserted patients, raising expectations that competition in clopidogrel will intensify again in the future. According to industry sources on the 13th, 13 bioequivalence tests on clopidogrel were approved just this year, 9 of which were approved after May this year. Compared to the average of 4.3 cases that were approved in the 3 years from 2018 to 2020, the number of tests increased significantly. Currently, 145 single compound clopidogrel products are approved in Korea. Most of the approvals were concentrated between 2005 and 2007. Around 40 products including Handok’s ‘Plavix,’ and Samjin’s ‘Platless’ were approved in this period. Since then, approvals continued sporadically until the second wave of approvals rushed in 2012-2013. A total of 35 items were approved during the period. And the atrial fibrillation prevention indication was added at the end of 2011, and the release of the aspirin combination has also increased approval of the single-ingredient clopidogrel. In addition, one of the reasons why bioequivalence tests are increasing for clopidogrel this year is because of the study results that were released last May. In May, Hyo-Soo Kim, Professor of Cardiology at the Seoul National University Hospital, presented the results of his study on patients who had undergone percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) comparing aspirin vs. clopidogrel as an antiplatelet agent. Professor Kim had directly compared the effect of clopidogrel and aspirin as a long-term maintenance therapy on patients who underwent PCI with a dual antiplatelet therapy (DAPT) regimen for 6 to 18 months. The study was conducted for 2 years in 37 hospitals in Korea, on 5,500 patients who underwent PCI. The results, which confirmed that clopidogrel is superior to aspirin, gained attention as all existing major treatment guidelines recommended aspirin as maintenance therapy after PCI. Professor Kim announced the results above at ACC 2021. As around 70,000-80,000 patients receive PCIs every year, and clopidogrel demonstrated a superior effect in Korean patients compared with aspirin, the front-line pharmaceutical companies have been positively responding to the study results. In fact, 9 of the 13 clopidogrel bioequivalence tests newly approved this year were submitted after the study was presented. And industry sources believe Samjin Pharmaceutical’s recent release of the high-dose product is not unrelated to the study results as well. Samjin Pharmaceutical was the first to release a 300mg clopidogrel product on the 12th. This was the first product line extension made by the company, 16 years after the 75mg dose was approved. Only 75mg products including the original are currently approved in Korea. However, the inconvenience of the ACS patients needing to take 4 tablets as the initial loading dose before receiving PCI was pointed out. The high-dose Platless that was released recently has improved this convenience with a single tablet, once-daily dose. An industry official said, “The clopidogrel ingredient treatment market has been continuously growing for the 20 years since its release with the popularization of PCIs. Also, with the latest study results demonstrating that clopidogrel is superior to aspirin as a long-term maintenance therapy, the competition in the clopidogrel treatment market will continue to intensify in the future.” According to the market research institution UBIST, the clopidogrel market last year sold ₩360 billion. In the market, the original Plavix was prescribed the most with ₩91.6 billion. Among the generics, Samjin’s Platless sold ₩61.2 billion, and Chong Kun Dang’s Pregrel sold ₩25.8 billion last year.
- Company
- ‘Ibrance’ opens new horizon as the lead CDK4/6 inhibitor
- by Oct 14, 2021 05:38am
- The breast cancer treatment ‘Ibrance (palbociclib)’ was what established Pfizer Korea as the ‘anticancer drug power’ in Korea. The company had other excellent anticancer drugs such as ‘Xalkori,’ and ‘Sutene,’ but none had received as much spotlight as Ibrance. As the ‘first CDK4/6 inhibitor,’ and ‘the first new breast cancer drug in 50 years,’ Ibrance had quickly rose to the ranks and became a blockbuster drug. ◆ The first CDK4/6 inhibitor, unrivaled status despite controversy Ibrance selectively inhibits Cyclin-dependent kinases (CDK) 4/6 that regulate cell division and cell growth to block the proliferation of tumor cells. Lilly’s Verzenio (abemaciclib),’ and Novartis’s ‘Kisqali (ribociclib)’ belong to CDK4/6 inhibitor class drugs. Among these drugs, Ibrance is the first drug in its class, the ‘first-in-class’ CDK 4/6 inhibitor. Ibrance is indicated for the treatment of breast cancer in combination with an aromatase inhibitor as first-line endocrine therapy in postmenopausal women or combination with fulvestrant in pre-and post-menopausal women with disease progression following endocrine therapy. For a year Ibrance was launched in Korea in August 2016, the field was full of expectations, disappointment, longing, and appeals. The introduction of a new drug with a new mechanism of action was blissful news. In particular, the patient population for Ibrance was wider than other drugs, as it targeted f hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. These patients had to use anti-hormonal drugs such as aromatase inhibitors or chemotherapy, which had many systemic side effects if not managed until Ibrance appeared. Before the introduction of Ibrance, this patient group had to use antihormonal therapy such as aromatase inhibitors, and if their condition was not managed with such therapies, use chemotherapy, which had many systemic side effects Korea was the fifth country to approve the drug. In December of the same year, the drug's efficacy and safety in Asian patients were verified through a clinical trial and rose as the drug that could change the breast cancer treatment paradigm. The National Comprehensive Cancer Network’s ‘Category 1’ recommendation of CDK4/6 inhibitors as combination therapy for the treatment of HR+/HER2- advanced/metastatic breast cancer had also contributed greatly to establishing the drug as standard care in breast cancer. However, Ibrance did not immediately rise and become the star after its release. The drug had suffered receiving reimbursement due to its high drug price, costing over ₩5 million per month. In particular, 2017 was the time when many high-price anticancer drugs were introduced and rejected reimbursement, and Pfizer Korea was put at a difficult price due to its difficulty in demonstrating cost-effectiveness, and the issue that Ibrance was more expensive in Korea than abroad. The Health Insurance Review and Assessment Service recognized Ibrance’s feasibility of reimbursement in July 2017, after rounds of review. However, the approval left much to be desired among patients because the reimbursement was only allowed as first-line endocrine therapy in postmenopausal women in combination with letrozole. Its use as second-line therapy in combination with fulvestrant was non-reimbursed, and premenopausal patients, which are much more prevalent in the East than in the West, were unable to receive the reimbursement benefit at all. The 2nd-line reimbursement of Ibrance+fulvestrant was only approved last July, 4 years after Ibrance’s approval. In addition, the fact that the drug was reimbursed at the same time with the CDK4/6 class latecomer Verzenio, left much to be desired for Ibrance. However still, Ibrance is fully exerting its strength as the ‘first’ introduced to its market. Among the three products in the CDK4/6 market, Ibrance has been dominating the market as the second drug, Verzenio, was approved in Korea three years later than Ibrance, in May 2019. The third CDK4/6 inhibitor Kisqali was approved 5 months after Verzenio, in October 2019 and listed for reimbursement in November last year. 자료: 아이큐비아 Ibrance raised annual sales of ₩40 billion in three years in the competitor-free market. According to the market research institution IQVIA, sales of Ibrance, which was ₩6.6 billion in 2017, surged 283% in 2018 to reach ₩25.3 billion after being listed for reimbursement. Then, sales rose 73% again to record ₩43.7 billion in 2019. Last year, Ibrance sold around ₩60 billion and is expected to sell near ₩70 billion this year. Compared to Ibrance’s quarterly sales, which is around ₩15 billion, Verzenio’s sold ₩3 billion, and Kisqali sold mid-₩1 billion range. ◆Three-way competition starts now… data will decide the winner With all three products now approved for reimbursement, the competition is finally in full pace. Of course, the other two drugs have a long way to go because they need to break down the solid position held by Ibrance in the market. Therefore, the latecomer drugs are betting in areas where Ibrance has not reached, as preoccupying new areas is easier than breaking down Ibrance's established position. The attempt will also support the expansion of the overall CDK4/6 inhibitor market amid the increased introduction of new-class drugs. One of the areas being targeted is early breast cancer. Despite its strength in metastatic breast cancer, Ibrance did not show as a good result in early breast cancer. In both the PALLAS study that tested Ibrance+endoctrine therapy as adjuvant therapy in hormone receptor-positive (HR+)/HER-2 negative (HER2-) metastatic breast cancer and the PENELOPE-B study that tested Ibrance+endoctrine therapy after neoadjuvant chemotherapy, Ibrance did not show a difference in invasive disease-free survival (iDFS) compared to placebo (primary endpoint). Pfizer believed the high early discontinuation rate due to the strict dose restriction and the short period of administration had an effect. On the other hand, Verzenio achieved its primary endpoint in a median follow-up period of 15.5 months as adjuvant therapy, suggesting the potential for scope expansion. Of course, whether using CDK4/6 inhibitor as adjuvant therapy in early breast cancer patients is more beneficial, remains a question that needs to be addressed. Kisqali can be used in combination with an aromatase inhibitor as first-line endocrine therapy in pre/perimenopausal women that cannot use Ibrance, and therefore may resolve the unmet needs of Ibrance. Also, Kisqali has demonstrated the longest overall survival period among all drugs, threatening Ibrance’s sole lead in the market.
- Company
- Korea Otsuka Pharma’s Hyangnam Plant rises as a global hub
- by Nho, Byung Chul Oct 14, 2021 05:38am
- Pic. of Korea Otsuka Pharmaceutical Korea Otsuka Pharmaceutical, which is soon to face its 40th anniversary in Korea, is receiving attention with its Hyangnam Plant rising as a forward base for global exports and production. Korea Otsuka Pharmaceutical is a global total healthcare enterprise that covers a wide range of businesses from clinical research, R&D, manufacturing, and export of pharmaceuticals. The company will celebrate its 40th anniversary in Korea in 2022. It is one of the rare multinational pharmaceutical companies in Korea that owns and operates a large-scale production facility locally in the Hyangnam Pharmaceutical Industrial Complex in Gyeonggi-do. 99% of the company’s pharmaceutical products released in Korea are supplied through the local Hyangnam plant, and Korea Otsuka Pharmaceutical has continuously invested in the manufacturing facility to expand the facility's role as Otsuka’s global hub. Established in 1989, Korea Otsuka Pharmaceutical’s Hyangnam Plant obtained KGMP approval in December 1990, and BGMP approval in December 1999. By obtaining approval from the US FDA as an API manufacturing facility in July 2000, the plant had grown into a production facility that covers the entire process of drug production from raw material synthesis to the finished product. Ever since its establishment, the company has been continuously investing in the production facility, gradually transforming the plant into a world-class production facility that can produce pharmaceuticals that meet global quality standards. In 2018, the plant was also selected as the first-ever Digital Medicine (DM) manufacturing site, raising expectations of expanding exports to North America after obtaining cGMP approval from the US FDA as well as contributing to further progressing the domestic pharmaceutical industry's production capability. Since the company started to reexport its products to Japan in 1991, Korea Otsuka Pharmaceutical has expanded exports to 13 countries in Asia including China, the Philippines, and Indonesia. In 2014, the company’s facility obtained EU-GMP approval and expanded its exports to 44 countries including those in Europe, raising over 40 billion won in annual exports. Based on the growing export sales, the company had been awarded the ‘$10 million export Tower’ in 1998, ‘$20 million export Tower’ in 2009, and ‘$30 million export Tower’ in 2015 for its outstanding export performance, contributing to the development of Korea's pharmaceutical industry through continuous job creation and the development of the domestic economy. Also, through continuous R&D investment and its independent R&D activity, the company has obtained new indications and developed new formulations, demonstrating the superior development capability of domestic researchers while increasing exports and expanding global approvals. In April this year, Korea Otsuka Pharmaceutical had succeeded in developing a global product- ‘Mucosta SR Tab.’ - for the treatment of gastric mucosal lesions using only domestic infrastructure through open innovation development with a domestic venture company, IMD Pharm, and Aju University Industry-Academic cooperation foundation. Such R&D investment activities are not irrelevant to the virtualization of its Hyangnam plant. The development of various new items with new indications and formulations led to expanded approvals in Korea and nearby countries, based on which the company has expanded exports of pharmaceuticals produced at its Hyangnam plant in Asia, Arab, and Europe regions. With the increased exports, the Hyangnam plant has been exerting its influence as a well-established production base of Otsuka Pharmaceutical. Meanwhile, Korea Otsuka Pharmaceutical has been the only multinational pharmaceutical company to be nominated as an ‘innovative pharmaceutical company’ for 4 consecutive years in recognition of its continuous investment in production facilities and activation of the domestic pharmaceutical industry.
- Company
- Tabrecta/ Rybrevant are expected to enter the market
- by Eo, Yun-Ho Oct 13, 2021 05:47am
- Two types of anticancer drugs targeting MET gene mutations are expected to enter the domestic market. According to related industries, Novartis Korea and Janssen Korea submitted applications to the MFDS for approval of the new anticancer drugs Tabrecta (Capmatinib) and Rybrevant (Amivantamab), respectively, and are currently undergoing screening. MET mutations are rare types that account for about 3% to 4% of metastatic non-small cell lung cancer, and interest in these new drugs is increasing as there have been no treatments. The two drugs have something in common that they target hepatocellular growth factor receptors (c-Met), but the indications are somewhat different. Tabrecta was first approved in the United States in May last year as a treatment for MET Exon14 mutated non-small cell lung cancer (NSCLC). In the case of Rybrevant, it obtained US approval in May, blocking epithelial cell growth factor (EGFR) and MET mutation at the same time. The first indication of this drug is non-small cell lung cancer with EGFR Exon20 mutation. Tabrecta and Rybrevant are spurring research for future combination therapy. In particular, it is expected to be able to solve the resistance problem of EGFR TKI in lung cancer. In fact, Tabrecta is conducting a clinical trial in combination with AstraZeneca's third-generation EGFR TKI Tabrecta (Osimertinib), while Rybrevant is conducting a study in combination with Yuhan's 'Leclaza(Lazertinib), a domestic new drug. Meanwhile, Tabrecta confirmed its validity through a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, DoR of previously untreated patients was 12.6 months and the patients treated were 9.7 months. Leclaza proved its efficacy through CHRYSALIS, a phase 1 clinical trial. According to the study, the objective response rate (ORR) was 40% when 81 patients with non-small cell lung cancer with 20 mutations of EGFR Exon were administered with Rybrevant. There were three patients with complete response (CR) with complete tumor disappearance, and 29 patients reached partial response (PR) with tumor size decreasing by more than 30%.
- Company
- ‘Rinvoq’ tries AD reimbursement following ‘Olumiant’
- by Eo, Yun-Ho Oct 12, 2021 05:50am
- Companies have been actively seeking insurance benefits for their JAK inhibitors in atopic dermatitis. According to industry sources, Abbvie Korea has also applied for the reimbursement of its ‘Rinvoq (upadacitinib)’ in atopic dermatitis after its indication expansion, following Lilly Korea’s reimbursement application for ‘Olumiant (baricitinib) in May. Rinvoq had been additionally approved for atopic dermatitis, ankylosing spondylitis, and psoriatic arthritis on October 5th. Also, with the application for Pfizer Korea’s ‘Cibinqo (abrocitinib)’ in process in addition to the two drugs, whether a viable new treatment option will be introduced to the field of atopic dermatitis following Sanofi-Aventis Korea’s ‘Dupixent (dupilumab),’ is receiving attention. For Dupixent, discussions are ongoing with the health insurance authorities on whether the drug’s reimbursement should be extended to cover pediatric·adolescent patients with atopic dermatitis. Rinvoq became the second JAK inhibitor following Olumiant to be approved to treat atopic dermatitis, a field that had few treatment options. Unlike Olumiant, which can only be used in adults, Rinvoq can also be used in adolescents 12 years or older. Rinvoq’s efficacy was verified through the Heads Up study, a head-to-head trial between Rinvoq and Dupixent. Study results showed that 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group. More recently, the patients’ eczema area was divided into 4 (head and neck, body, arm, leg) to assess the rate of EASI 75 response at Week 16 in the areas. EASI 75 rates at Week 1 in all 4 areas were higher for Rinvoq and continued until Week 16. In other words, the study indicated that Rinvoq can relieve symptoms faster than Dupixent, regardless of the affected area. However, the safety issue of JAK inhibitors as a whole is on the board. Based on the post-marketing safety study of Xeljanz, the US FDA had issued a Dear HCP letter warning of the risk of heart attacks in JAK inhibitors such as Xeljanz, Olumiant, and Abbvie's 'Rinvoq (upadacitinib).’ Whether this issue can be resolved and the drugs can settle as a treatment option in the field of atopic dermatitis remains to be seen.
- Company
- SK Bioscience will also produce COVID-19 vaccines next year
- by Chon, Seung-Hyun Oct 12, 2021 05:49am
- At an agreement ceremony held in Brussels, Belgium on the 5th, SK Bioscience President Ahn Jae-yong (right side of the picture) and CEPI CEO Richard Hatcht are signing a contract to use the Andong L House facility SK Bioscience will also entrust production of COVID-19 vaccines from global pharmaceutical companies next year. SK Bioscience announced on the 5th that it has signed an extension contract for the use of Andong L House facilities with CEPI in Brussels, Belgium. It will extend the period of using some of the undiluted production facilities in Andong, which were signed in June last year and are about to expire at the end of this year, to the end of 2022 for the production of COVID-19 vaccines by CEPI-supported companies. The contract said that by the end of next year, three of SK Bioscience's facilities in L-house will be used first to entrust production of the COVID-19 vaccine developed by a company supported by CEPI. The two companies agreed to continue close cooperation to overcome the current pandemic situation and expand cooperation in research on various infectious diseases that have frequently occurred recently and the development of vaccines accordingly. SK Bioscience participated in the world's efforts to prevent the spread of COVID-19 infection and discussed "1 Euro" with only symbolic meaning as an initial down payment to maintain friendly cooperation with international organizations such as CEPI and COVAX facilities. CEPI has decided to continue to utilize SK Bioscience's facilities as a public goal to secure fair vaccine access by supplying additional COVID-19 vaccines around the world through the COVAX facility. COVAX facility currently plans to supply a total of 2 billion doses of COVID-19 vaccine to the world by the first quarter of next year. SK Bioscience plans to accelerate the development of its own COVID-19 vaccine, which is currently in phase 3 clinical trials, in close cooperation with CEPI. The COVID-19 vaccine candidate GBP510 jointly developed by SK Bioscience and Institute for Protein Design (IPD) and using GlaxoSmithKline's Pandemic Technology is currently in phase 3 clinical trials. CEPI cooperated with the Bill & Melinda Gates Foundation from the initial development stage of the GBP510 and provided SK Bioscience with up to USD 213.7 million in development funds. GBP510 was selected as the first target of the 2nd generation COVID-19 vaccine project operated by CEPI last year to support differentiated COVID-19 vaccine candidate materials. When GBP510 is commercialized, hundreds of millions of vaccinations will be supplied worldwide, including underdeveloped countries. SK Bioscience and CEPI are additionally discussing the development of GBP510 in preparation for variations and research on booster shots. "The additional facility use contract with SK will provide an opportunity to approach the promise of COVAX facilities to protect vulnerable populations through fair vaccine supply, while further strengthening the relationship between CEPI and COVAX facilities and South Korea," said Richard Hatchett, CEO of CEPI. Ahn Jae-yong, president of SK Bioscience, said, "The proven production system and technology shown by global companies during consignment production of the COVID-19 vaccine led to an extension contract with CEPI." Next year, we will secure and supply our own COVID-19 vaccine, which will serve as a hub for global vaccine supply, he said.
- Company
- Dupixent reimbursement in pediatric AD is being discussed
- by Eo, Yun-Ho Oct 08, 2021 05:57am
- Discussion on prescribing ‘Dupixent’ to pediatric patients with atopic dermatitis is now showing visible progress. According to industry sources, the National Health Insurance Service has started expert inquiries to start discussions on applying insurance benefits to the lower-dose (200mg) formulation of Sanofi-Aventis Korea’s Dupixent (dupilumab). This is 7 months since the company had applied for reimbursement in April. Accordingly, other processes including its deliberation date by the disease subcommittee, etc. are expected to be soon set. The lower-dose Dupixent was approved in Korea in adolescent patients aged 12 or older with severe atopic dermatitis who are less than 60kg. After an initial dose of 400mg, the patient is administered 200 mg every other week. Since then, Sanofi added the indication for treating pediatric patients aged 6 to 11 with severe atopic dermatitis for its low-dose formulation and then applied for its reimbursement listing. The health insurance benefit for Dupxient is approved for adult patients aged 18 or older with 3+ years of medical history with severe chronic atopic dermatitis that meets all three standards: ▲ unable to control symptoms even with first-line topical therapy for 4 or more weeks; ▲ cannot use systemic immunosuppressants due to no response or side effects despite 3 or more months of use; ▲ had an EASI (Eczema Severity Assessment Index) of 23 or higher before using Dupixent. This is for the 300mg dose. The efficacy and safety of 200mg Dupixent were verified through the LIBERTY AD ADOL clinical trial. 251 adolescent patients with severe atopic dermatitis patients who were treated with Dupixent 200mg and 300mg showed a 66% improvement in the size of lesion and severity at week 16, as well as clinically significant improvement in their quality of life index. 75% of the group that was administered Dupixent in combination with topical corticosteroids, achieved EASI 75 (EAST improvement of 75%) at week 16, demonstrating a more significant improvement compared to the 26.8% of the placebo group. Since Dupixent, other JAK inhibitors used for autoimmune diseases like rheumatoid arthritis have also been seeking to enter the atopic dermatitis treatment market. In June, Lilly Korea submitted a reimbursement application for ‘Olumiant (baricitinib),’ and Abbvie Korea has recently added an AD indication for its ‘Rinvoq (upadacitinib).’ Also, Pfizer applied for domestic approval of ‘Cibinqo (abrocitinib)’ recently.
- Company
- PARP inhibitor Zejula, which is partially covered
- by Oct 08, 2021 05:57am
- PARP inhibitor Zejula could be reimbursed as the primary maintenance therapy for ovarian cancer. However, it is pointed out that "regulatory agencies should change their perspectives" due to benefit standards. Kim Jaewon, professor of obstetrics and gynecology at Seoul National University Hospital, is taking Korea on the 7th. At the Zejula online meeting held by the restriction, he pointed out, "It is regrettable that only ovarian cancer patients with BRCA mutations have recognized primary maintenance benefits. This is in accordance with the stereotypes of regulators, and we need to change our perspective like in the United States." Earlier, the Health Insurance Review and Assessment Service recognized the clinical usefulness of primary maintenance therapy only for BRCA positive. Regulatory authorities believe that Zejula can be used regardless of the BRCA mutation, but the application of benefits is insufficient. Professor Kim Jaewon The underlying PRIMA clinical results showed that Zejula showed a median progression-free survival (mPFS) of at least twice as long as that of placebo groups in the entire patient group, regardless of BRCA mutation and covalent recombinant deficiency (HRd) (21.9 months vs. 10.4 months). The risk of disease progression and death also decreased by 57%. The effect was highest in the BRCA-positive patient group. The mPFS of BRCA-positive patients in the HRd patient group was 22.1 months in the Zejula-administered group and 10.9 months in the placebo group. However, even in the BRCA negative patient group, mPFS satisfies statistical significance to 19.6 months in the administration group and 8.2 months in the placebo group, allowing Zejula to extend the progression-free survival period regardless of the BRCA mutation. Jang Hyun-ah of Takeda Pharmaceutical Korea said, "In terms of PRIMA results, Zejula showed consistent treatment effects regardless of biomarkers, including patients in high-risk groups." She also explained, "We also confirmed that the dose can be adjusted and used according to the patient's condition, and that even if the capacity is low, there is no difference in effect and the safety profile improves." The reason for dissatisfaction with the disapproval of benefits in the BRCA negative group is that more than 80% of ovarian cancer patients do not have a BRCA mutation. Patients are suggesting expanding their salaries so that many people can take the first PARP inhibitor that can be used regardless of BRCA mutation. Professor Kim Jae-won also said, "There are quite a few patients who benefit from HRp, not HRd, without biomarker mutations." He said, "A similar thing happened in the United States five to six years ago, but the PARP inhibitor was accepted by changing the perspective to an advanced survival period according to the characteristics of ovarian cancer. "I think the government should cover all of them regardless of mutations with insurance benefits because many of them can be cured if they use drugs," he said. 제줄라 국내 허가사항과 급여 현황(자료: 한국다케다제약)
- Company
- Lynparza was approved for pancreatic cancer/ prostate cancer
- by Oct 08, 2021 05:56am
- PARP inhibitor "Lynparza (Olaparib)" has expanded its indications to pancreatic and prostate cancer. AstraZeneca Korea announced on the 7th that it has been approved by the MFDS for Lynparza's indications for pancreatic and prostate cancer. As a result, Lynparza can be used for ▲ maintenance therapy in adult patients with gBRCA mutated pancreatic cancer who have not undergone chemotherapy for at least 16 weeks after receiving 1st platinum-based chemotherapy and ▲ for treating adult patients with BRCA mutated metastatic castration-resistant prostate cancer who have previously progressed after treatment of new hormone treatments. The approval for pancreatic cancer and prostate cancer indications was based on clinical studies of POLO3 and PROfound4, respectively. In a POLO phase 3 study evaluating the efficacy of Lynparza maintenance therapy in pancreatic cancer patients with reproductive cell BRCA (gBRCA), the median progression-free survival period (PFS) of the Lynparza administration group was 7.4 months, nearly doubling compared to placebo (3.8 months). Approval for prostate cancer indications was based on the results of sub-analysis of patients with BRCA1/2 mutation in a PROFUND phase 3 study [3] in patients with HRR mutation metastatic castration resistant prostate cancer. In this study, Lynparza reduced the risk of disease progression and death by 78% in patients with BRCA1/2 mutation among the target patients, and the median radiological progression-free survival period (rPFS) was 9.8 months, showing improved results than enzalutamideAAbiraterone of 3.0 months. In addition, the median overall survival period (OS) of the enzalutamideAAbiraterone group was 14.4 months, while the Lynparza administered group recorded 20.1 months, lowering the risk of death by 37%. "Lynparza is the first ARP inhibitor to expand indications in two carcinomas, pancreatic cancer and prostate cancer, showing clinical usefulness in two carcinomas that had high incomplete demand," said Myung Jin, executive director of the anticancer drug division. In particular, metastatic pancreatic cancer and metastatic castration-resistant prostate cancer are all the more meaningful in that treatment options have been limited, he said.
