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- 2026-03-16 23:45:11
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- Keytruda indication has been expanded
- by Jul 26, 2022 06:05am
- The immuno-cancer drug Keytruda has expanded its treatment indication to early triple negative breast cancer following metastaticity. With the addition of Keytruda to adjuvant therapy before and after surgery, it is expected to contribute to reducing the recurrence rate by using immuno-cancer drugs early. MSD Korea held a press conference at the Bank Hall in Jung-gu, Seoul on the 22nd and highlighted the meaning of Keytruda's approval of adjuvant therapy before and after early triple negative breast cancer surgery. Keytruda expanded its scope to supplementary therapy before and after surgery for early triple negative breast cancer a year after obtaining indications for the first treatment of recurrent and metastatic triple negative breast cancer in July last year. It can be used as a kitruda-antio-cancer chemotherapy (Carboplatin+Paclitaxel, Doxorubicin or Epirubicin+Cyclophosphamide) as an auxiliary therapy before ▲ surgery in patients with stage 2 triple negative breast cancer who have no treatment experience, and ▲ after surgery, administer it alone as an adjuvant therapy. According to phase 3 clinical study of 1,174 people, Keytruda-antcancer chemotherapy group in preoperative adjuvant therapy significantly extended its safe survival by reducing the progression of non-permanent chemotherapy, local and remote recurrence, secondary primary cancer, and death risk from all causes by 37% compared to the risk. For 36 months, the Event-free Survival was 84.5%, significantly higher than the control group of 76.8%. At 15.5 months of median follow-up observation period, the pathological pCR of the adjuvant therapy before and after Keytruda surgery was 64.8%, showing a statistically significant difference compared to 51.2% of chemotherapy alone. The Keytruda group showed superior pCR tendency regardless of PD-L1 expression rate. Accordingly, the Ministry of Food and Drug Safety allowed Keytruda to be used as an adjuvant therapy before and after surgery without performing a PD-L1 expression test. Safety was similar to the safety profile of chemotherapy and Keytruda monotherapy used in patients with Triple-Negative Breast Cancer (TNBC), and no new safety issues were reported. Most immune-mediated adverse reactions appeared in preoperative adjuvant therapy, and in postoperative adjuvant therapy, they were manageable at a low grade. Professor Park Yeon-hee, head of the clinical trial center at Samsung Medical Center, who participated in the clinical trial, said, "Pre-operative chemotherapy options were in high demand for new treatment options because only cytotoxic anticancer drugs were available." TNBC is considered a cancer with poor prognosis due to frequent metastasis to other organs within two to three years after diagnosis and a short survival period after recurrence, but there is no target treatment. The socioeconomic burden is also high due to the relatively high proportion of young patients under the age of 50. Professor Park said, "TNBC has higher benefits for early chemotherapy. As a precautionary measure to reduce recurrence, Keytruda-based advanced chemotherapy is considered a cost-effective area, he said. "It would be great if many patients could benefit from the rapid payment." Kim Sung-pil, executive director of MSD Korea's anticancer drug business division, also said, "We will try to proceed with Keytruda's benefit as soon as possible at TNBC. As the indication of Keytruda has increased, we are recently discussing a new strategy for additional benefit at urothelial carcinoma."
- Company
- Evusheld can be prescribed in Korea
- by Eo, Yun-Ho Jul 26, 2022 06:05am
- COVID-19 preventive drug Evusheld has begun preparing for actual prescriptions. According to related industries, AstraZeneca's Evusheld passed the Drug Committee of 200 medical institutions nationwide, including the Big 5 Advanced General Hospitals such as Seoul National University Hospital and Samsung Medical Center through the Korea Centers for Disease Control and Prevention. In May, the government spent 39.6 billion won to introduce 20,000 doses of Evusheld, an antibody treatment for the purpose of preventing COVID-19 infections and severe diseases to protect severe immune deficiencies. Since then, the Ministry of Food and Drug Safety has confirmed the emergency use approval of Evusheld on the 30th of last month. As a result, Evusheld, the first antibody complex for preventing the COVID-19 virus in Korea, is expected to be prescribed to immunocompromised patients. It is judged that the subject of administration will be limited. The government limited the subjects of Evusheld to patients undergoing severe immunosuppressive treatment, which requires preventive antibody treatments, rather than those with diseases that require immunosuppressive treatment. People with a history of COVID-19 confirmed were also excluded. As a result of the report, it was confirmed that the health authorities conveyed their intention to the National Assembly to discuss the increase by using reserve funds in consideration of the future epidemic situation, the need to expand and re-administrate targets. The U.S. FDA approved Evusheld last December. The European EMA confirmed the introduction in March. In addition, France, Australia, and Singapore have completed pre-purchase contracts for Evusheld to prevent COVID-19. An AstraZeneca official said, "We hope it will help immunocompromised patients such as blood cancer and organ transplant patients who were in the blind spot of COVID-19 prevention, and we will continue to do our best to provide smooth domestic supply." Through various studies published in Nature Medicine, it has been confirmed that Evusheld is the only antibody agent to maintain neutralization activity against omicron mutations, covering both BA.1 and BA. 2. As a result of PROVENT study, Nature Medicine reduced the risk of symptomatic COVID-19 infection by 77% compared to placebo in the first analysis, and 83% decreased the risk in 6-month follow-up. During the 6-month follow-up period, there were no cases of severe or death in the Nature Medicine group. More than 75% of the subjects who participated in the study had companion diseases that were likely to develop into severe symptoms when infected with COVID-19, such as weakened immune systems at the baseline or not showing sufficient immune responses to vaccination.
- Company
- EC market, occupied more than 70% of Bayer and Hyundai
- by Nho, Byung Chul Jul 25, 2022 05:58am
- In the emergency contraceptive market worth 15 billion won, Hyundai Pharmaceutical and Bayer have a market share of more than 70%, effectively dominating the market. Bayer Mirena has performed in the 6 billion won range for loop-type emergency contraceptives, and Hyundai's Norebwon and Ellaone have performed in the 5 billion won range for emergency contraceptives. PO emergency contraceptives are divided into two drugs, Levonorgestrel and Ulipristal Acetate, and the leading products consisting of these main ingredients are also Norebwon and Ellaone. As of 2021, Levonorgestrel's market share accounted for 77%, and the 2018~·2021 external appearance recorded 9.9 billion won, 10.5 billion won, 11.2 billion won. During the same period, sales of Ulipristic Acetate, which has a market dominance of about 23%, have been showing negative growth of 5.2 billion won, 5.2 billion won, 3.8 billion won, and 3.2 billion won. There are 18 products that are competing in the market with Levonorgestrel as the main ingredient, including Mirena, NorLevo, 72H Tab, Kyleena, PHOSTINO-1, Levonia, Noges One, Imeotra, and Sexcon. Among them, Bayer's Mirena, which has IUD, made 6.5 billion won in sales last year. Mirena's performance in 2018-2020 was 4.7 billion won, 6 billion won, and 5.7 billion won, which has remained unchanged for the past four years. Norebwon's sales in 2021 were 2.2 billion won, which is a -21% decrease in appearance after achieving its biggest performance of 2.8 billion won in 2018. In the case of Mirena, Hyundai's No. 1 PO product is maintained through the IUD method. Sales perfromance of THEU's 72H, Bayer's Kyleena, GI Medicine' PHOSTINO-1, and Myungmoon's Levonia 2021 is 900 million won, 600 million won, 400 million won, and 200 million won, respectively. Ulipristal Acetate is competing with Hyundai Pharmaceutical's Ellaowon and Shin Poong's Inisia, but the trend seems to be Ellaowon. Ellaowon earned 3.2 billion won in sales last year, and has consistently maintained sales in the early and mid 3 billion won range, becoming the No. 1 player in the same ingredient market. Inisia achieved 2.3 billion won in the second quarter to fourth quarter of 2017, and was expected to reverse its appearance due to a 200 million won gap with Ellaowon, but it has been showing sluggish sales compared to competitive drugs since 2018. Inisia's sales from 2018 to 2020 are 1.8 billion won, 1.6 billion won, and 560 million won, and it is expected that it has virtually lost its market dominance as its performance in the first quarter of 2021 and 2022 has not been determined. Ellaowon should take one tablet within 120 hours (5 days) at the latest after failing contraception, and if vomiting within 3 hours after taking it, immediately take one tablet again. It can be taken regardless of meals and can be taken at any time during the menstrual cycle. In the case of Norebwon, in principle, it should be taken as soon as possible (recommended within 12 hours) after the failure of contraception, and it can be used at any time during the menstrual cycle. If vomiting within 3 hours of taking it, one tablet should be taken again immediately, as in Ellaowon.
- Company
- He Young Lee appointed new head of BMS Korea
- by Eo, Yun-Ho Jul 25, 2022 05:57am
- Country Manager He Young Lee He Young Lee, the current Country Manager of Viatris Korea, has been appointed the new head of BMS Korea. According to industry sources, BMS Korea had carried out the recruitment process after the current General Manager (46), Jinyoung Kim, was transferred to the Global Compliance Organization, after which He Young Lee was nominated as the new head. With the appointment, Lee will resign from Viatris as of this month (July) and join BMS. Lee, who was appointed the first CEO of Viatris Korea after its spin-off from Pfizer, accumulated over 20 years of experience in the industry after graduating from the Seoul National University School of Pharmacy and acquiring an MBA from Korea University. Since joining Pfizer Korea in 2000, Lee served various posts in various departments, from clinical research, project development, to strategy&planning and served as the Marketing Director of the Primary Care Business as well as the CV TA Lead of the GEP (Global Established Product) Business in Shanghai and Hong Kong. Lee then served as the Country Manager of Pfizer Singapore, after which she was appointed the Vice President and Korea Lead of Pfizer Established Health to return to Korea. In November 2020, Pfizer Upjohn Korea became part of Global Viatris, and Lee was appointed Country Manager of Viatris Korea. A company official said, “Viatris’s business will continue as usual. Amr Ammar, Head of Commercial Development, Emerging Markets at Viatris will work closely with executives in Korea to ensure that operations run smoothly as planned."
- Company
- Heart failure guidelines revised for the first time in 6 yrs
- by Jul 25, 2022 05:57am
- The clinical practice guidelines for heart failure have been completely revised for the first time in 6 years. The new guideline contains all the latest drugs ranging from SGLT-2 inhibitors that demonstrated an effect in heart failure, angiotensin receptor-neprilysin inhibitors (ARNIs) that are represented by the Entresto, to the recently approved vericiguat. On the 22nd, the Korean Society of Heart Failure (KSHF) held an online press conference to celebrate the publication of the “Completely Revised Heart Failure Clinical Practice Guidelines 2022,” and announced the significance of the revision and the 10 important changes that were made. KSHF presents the “Completely Revised Heart Failure Clinical Practice Guidelines 2022,” The guideline had been completely revised for the first time in 6 years. The development of the Korean heart failure clinical practice guidelines started in 2016 when the KSHF first published a guideline for chronic heart failure, and then for acute heart failure in 2017. The guidelines underwent two partial updates in 2018 and 2020. Completely Revised Heart Failure Clinical Practice Guidelines 2022” consists of 64 chapters and 300 pages that reflect all the changes that were made over the past 5-6 years as well as the latest Korean and global research results. The major revisions include ▲the Definition and Classification of HF ▲HF diagnosis algorithm ▲Treatment of HF with reduced ejection fraction, ▲Changes in the roles of HF medicines (focusing on ARNI and SGLT2) ▲HF patients with improved ejection fraction ▲Treatment of HFmrEF and HFpEH ▲Treatment of comorbidities in HF patients ▲ Diagnosis and Treatment of cardiac amyloidosis ▲Period for transferring HF patients to tertiary hospitals or HF specialists ▲Treatment of acute HF patients and severe HF. The revision first made a more detailed classification and definition of HF. In the past, patients with an ejection fraction rate of 41-49% were considered to have a similar condition to “heart failure with preserved ejection fraction (HFpEF).” However, with studies reporting that the patient group shows similar drug treatment effects with the “Heart Failure with reduced EF (HFrEF)” group, the KSHF decided to classify the patient group as “Heart Failure with mildly reduced EF (HFmrEF)” The society also presented appropriate treatment methods in line with the newly set HF classification, as new treatments were introduced to treat HFpEF, a field that had high unmet needs with no suitable available treatment. While reflecting the international HF guidelines, such as those that were revised in the US in April 2022 and Europe in 2021, KSHF provided a standardized, optimal HF treatment guideline for Koreans whose recommendations align with the contents necessary and real to Korea. Source : KSHF In the guidelines, ARNI (angiotensin receptor-neprilysin inhibitors) or angiotensin-converting enzyme inhibitor (angiotensin receptor blocker for intolerant patients), beta blocker, saline corticoid receptor antagonist (aldosterone antagonist), and SGLT-2 inhibitors were recommended (Class I, Level of Evidence) as first-line standard of care in HFrEF. SGLT-2 inhibitors were recommended for administration regardless of the patient’s diabetic status to reduce hospitalization from HF or cardiovascular deaths. In addition, the new guidelines recommended patients continue receiving the standard of care treatment even if the patient’s symptoms improve and EF increases to 40% or higher after standard of care. (Class I, Level of Evidence B). If EF continues to decrease despite standard drug therapy, the guidelines recommend treatments such as ivabradine, vericiguat, or digoxin as second-line treatments Also, diuretics, SGLT2 inhibitors, and ARNIs were recommended as primary treatments for HFmrEF and HFpEF, In the HFmrEF and HFpEF group, diuretics and SGLT2 inhibitors (empagliflozin or dapagliflozin) were recommended as a priority (Class I), and ARNI was then recommended (Class IIa, Level of Evidence B) Hyun-Jae Cho, Director of Clinical Practice Guidelines in KSHF (Professor of Cardiology at SNUH), said, “The revised guidelines contain updated definition and classification of HF that is more detailed than before. The changed treatment methods and drug recommendations are also included in detail.”
- Company
- How will the prescription market react?
- by Chon, Seung-Hyun Jul 25, 2022 05:57am
- Pharmaceutical companies are also paying keen attention to the rapid increase in the number of COVID-19 confirmed cases this month. Since the spread of COVID-19 in the past two years, the prescription market seems to be closely watching recent changes in the situation. According to the Central Disease Control Headquarters of the Korea Centers for Disease Control and Prevention on the 20th, a total of 76,402 new COVID-19 confirmed patients were counted as of 0 o'clock that day. The figure was 73,582 on the 19th, the largest in 83 days since April 27 (76,765), and the figure was 70,000 for two consecutive days. The "double" phenomenon, in which the number of confirmed cases doubled compared to the previous week, has continued for three weeks. The pharmaceutical industry seems to be closely watching the impact of the surge in COVID-19 confirmed patients on the prescription market. The domestic prescription drug market seems to have regained its previous year's upward trend this year after slowing down until last year after the spread of COVID-19. According to UBIST, a pharmaceutical research institute, the total amount of outpatient prescriptions in the first half of this year was 8.2874 trillion won, up 6.1% from 7.8129 trillion won in the same period last year. It increased 6.5% year-on-year to 4.1248 trillion won in the first quarter, and increased 5.7% year-on-year in the second quarter. It has achieved higher growth than in 2020 and 2021. The prescription amount in the first half of 2020 and 2021 grew only 2.9% and 2.6%, respectively, compared to the previous year. This year means that the growth rate of the prescription drug market is more than twice as high as that of the past two years. Analysts say that this year's recovery in the prescription drug market is related to a surge in the number of COVID-19 confirmed patients. Earlier this year, as many as hundreds of thousands of COVID-19 confirmed patients poured out a day, prescriptions for antipyretic painkillers, cold medicines, and antibiotics used to alleviate COVID-19 symptoms increased significantly. As the supply of cold medicines has not kept up with demand, the government has encouraged pharmaceutical companies to increase production and even received weekly reports of production and inventory. This is quite different from the two-year slowdown in the prescription drug market in the aftermath of COVID-19 until last year after the spread of COVID-19. In 2020, when COVID-19 began to spread, the amount of outpatient prescriptions was15.6365 trillion won, up 2.7% from the previous year. Outpatient prescription performance last year was 16.1126 trillion won, an increase of only 3.0% from the previous year. The amount of prescriptions in 2018 and 2019 increased by 8.1% and 8.2% compared to the previous year, respectively, and the growth rate fell by one-third for the second consecutive year since the spread of COVID-19. It is analyzed that COVID-19 has directly contributed to the sluggish prescription drug market over the past two years. After the spread of COVID-19, strengthening personal hygiene management such as hand washing and wearing masks has greatly reduced the incidence of infectious diseases, leading to a decrease in visits to medical institutions. Looking at the quarterly prescription market trend until last year after the spread of COVID-19, the growth rate exceeded 5% in the third quarter of 2020 and the fourth quarter of last year alone. For the rest, the growth rate of quarterly prescriptions remained between 0 and 3.2 % compared to the previous year. In the second quarter of 2020, the prescription scale growth rate was only 0.7%, and as COVID-19 spread in earnest, chronic patients such as HTN and DM avoided visiting medical institutions and received long-term prescriptions, there was a gap in the prescription market. In the fourth quarter of 2020, the growth rate of the prescription market was 0.0%. At that time, the market for prescription drugs seems to have been reduced due to a decrease in hospital visits due to a decrease in people's external activities as the operation of entertainment bars and singing practice centers was suspended and the number of restaurants was limited. Despite the same COVID-19 spread issue, the prescription market was also affected by the opposite depending on the social atmosphere.
- Company
- Strong dollar slows sales of Epis’s 3 biosimilars in Europe
- by Jul 22, 2022 05:53am
- (From the left) Product pictures of Benepali, Imraldi, Flixabi The 3 autoimmune disorder biosimilars developed by Samsung Bioepis (Benepali, Imraldi, Flixabi) made slower sales in Europe in the first half of this year. Total sales fell by 4.7% compared to the previous year. Sales of the products had suffered a hard blow from the recent strong dollar and the continued pressure to cut prices. According to the Biogen’s earnings call that was on the 21st (local time), the 3 biosimilars Benepali, Imraldi, and Flixabi made $388.2 million (₩510.1 billion) in sales in the period. This is a 4.7% drop YoY from the $407.5 million (₩535.5 billion) the products had made in the same period last year. Benepali’s sales dropped 5.2% to $230.5 million (₩302.9 billion) and Flixabi’s sales dropped 15.4 % to $43 million (₩56.6 billion). Only Imraldi’s sales rose 1.1% to $114.7 million (₩150.7 billion). Unit: $1 million, Data: Biogen Samsung Bioepis has been selling three of its biosimilars through Biogen in Europe. Benepali is a biosimilar of Pfizer’s TNF- α inhibitor ‘Enbrel,’ and Imraldi is a biosimilar of Abbive’s TNF- α inhibitor ‘Humira.’ Flixabi is a biosimilar of Johnson&Johnson’s TNF- α inhibitor ‘Remicade.’ All three are used to treat autoimmune disorders. The three biosimilars, which had raised slightly less than $200 million in sales in 2019, had first recorded $219 million (₩287.7 billion) in Q1 2020. In the second quarter that immediately followed, sales were stagnant at first due to the explosive increase in the number of confirmed cases of COVID-19 across Europe but rebounded since. In Q4 last year, it made a new sales record of $220.9 million (₩290.2 billion). This year, sales of the three types of biosimilars have again shown a decreasing trend. In Q1, sales of the three biosimilars were $194.3 million (₩255.3 billion), which fell 12% from the previous quarter. Sales continue to decrease in Q2, making $193.9 million (₩254.7 billion). It is believed that the exchange rate and price pressure caused by the strong dollar had an impact on sales. In fixed currency rates, Biogen mentioned that sales increased by 3%. "Although production of biosimilars had increased, this increase was offset by exchange rate effect and price pressure. As in last year, revenue from biosimilars will continue to decrease this year.” With sales of the current three autoimmune disease biosimilars expected to remain at that level, attention is rising on ‘Byooviz,’ which was developed by Samsung Bioepis. Byooviz is a biosimilar of the blockbuster age-related macular degeneration (AMD) drug ‘Lucentis’ and the first product Samsung Bioepis showcased in ophthalmology. The drug was approved as the first Lucentis biosimilar in the US and was released in June. Biogen will be in charge of selling Byooviz in the US. According to Biogen, Byooviz made $500,000(₩700 million) in the first month of its release in the US
- Company
- Takeda's anti-cancer drug Exkivity has been approved
- by Jul 22, 2022 05:53am
- A second targeted anticancer drug targeting EGFR Exxon 20 insertion mutation has emerged. Takeda Pharmaceutical Korea announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for the EGFR Exxon 20 insertion mutant non-small cell lung cancer treatment Exkivity (Mobocertinib). Exkivity is a TKI that inhibits the growth of cancer cells by targeting the EGFR Exxon20 insertion mutation gene. With this permit, Exkivity can be used to treat locally advanced or NSCLC adult patients with EGFR Exxon 20 insertion mutations that have previously been treated with platinum-based chemotherapy. EGFR exon20 insertion mutations are rare, accounting for about 10% of EGFR mutations in non-small cell lung cancer and about 2% in all non-small cell lung cancer. EGFR Exxon20 insertion mutation Non-small cell lung cancer has a survival period twice as short as that of Exxon19 deficiency and Exon21 (L858R) replacement mutation, which accounts for most of the EGFR mutation. In addition, the prognosis for existing first and second-generation EGFR TKI target treatments and immunotherapy was poor and the response rate was low, so most patients used platinum-based chemotherapy for treatment, so the demand for unmet Exxon20 insertion mutation target treatments was high. Exkivity is an irreversible binding to EGFR Exxon20 insertion mutations that inhibit cancer cell growth and proliferation with a mechanism that blocks binding to ATP, the energy source of cancer cells. Earlier in February, Janssen's Rybrevant, which targets EGFR Exxon 20 insertion mutations, was approved. Unlike the injection Rybrevant, Exkivity is an oral drug Exkivity is the first oral treatment for EGFR Exxon 20 insertion mutant non-small cell lung cancer, which can be taken once a day regardless of meals. The company explained that this not only improves the convenience of taking medicine compared to injections, but also makes it easy to control the dose for adverse reactions, which can help patients improve their quality of life while maintaining their daily lives. The approval was based on a phase 1/2 clinical study conducted on 114 patients with EGFR Exxon20 insertion mutant non-small cell lung cancer who previously received platinum-based chemotherapy. As a result of the clinical trial, the ORR evaluated by IRC was 28% and the mDOR was 17.5 months in the patient group who took 160 mg of Exkivity. In particular, the median reaction time after administration of Exkivity was 1.9 months, and it was confirmed that the drug effect quickly appeared from the beginning of treatment. The mPFS was 7.3 months and the MOS was 24.0 months. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, and can be managed by controlling the dosage. Ahn Myung-joo, a professor of hematologic oncology at Samsung Medical Center, said, "We are very pleased to hear the news of the domestic approval of Exkivity, as the target treatment options have been limited in EGFR Exxon 20 insertion mutant non-small cell lung cancer. The EGFR Exxon 20 insertion mutation had a poor prognosis even with existing treatment options, but Exkivity improved major indicators such as ORR and mPFS median through clinical studies."
- Company
- Imbruvica makes 4th attempt to extend reimbursement
- by Eo, Yun-Ho Jul 21, 2022 06:04am
- Already for the fourth time, Janssen is attempting to expand reimbursement for ‘Imbruvica’ as a first-line treatment. According to industry sources, reimbursement of Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) will once again be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Imbruvica’s reimbursement for its first-line indication, which had been deliberated by the CDDC three times from October last year to June this year, had been turned down all three times. The drug was able to receive reimbursement extensions to the second line after being listed through the PE exemption pathway but is having trouble extending its indication further into the first line. However, with voices rising on the need to extend Imbruvica’s reimbursement and HIRA's judgment that there is no problem in Imbrvica's clinical efficacy, there is a possibility that the company will finally see positive results if it proposes an appropriate fiscal sharing plan this time. In fact, the industry’s expectations are rising the agenda is expected to be deliberated at the next CDDC meeting after being turned down at the meeting that immediately preceded it. Imbruvica is a first-in-class oral Bruton's Tyrosine Kinase (BTK) inhibitor that is taken once daily. With its oral formulation, the drug has the strength of being able to be administered in the outpatient setting. Since it was approved in April 2018, the drug is being used as ▲ a second-line treatment for adult patients with recurrent or refractory CLL, ▲monotherapy for the treatment of adult patients aged 65 years or older with previously untreated CLL, ▲ combination therapy with obinutuzumab for the treatment of adult CLL patients over the age of 65 or those who have comorbidities or at high-risk under the age of 65 with previously untreated CLL.
- Company
- Tabrecta is scheduled to be introduced in August
- by Eo, Yun-Ho Jul 20, 2022 05:50am
- MET anticancer drugs will enter the first stage of registration of insurance benefits. According to related industries, Tabrecta will be introduced to the HIRA Cancer Disease Review Committee on August 10. Tabrecta was approved in Korea in November last year as a non-small cell Lung Cancer (NSCLC) treatment that confirmed MET Exxon 14 deficiency as the first MET inhibitor. MET mutations are a rare type that accounts for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Effectiveness was confirmed through GEOMETRY mono-1 study in 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 the previously untreated patient was 12.6 months, and DoR of the treated patient was 9.7 months. Tabrecta is also stepping up research for future combination therapy. In particular, it is expected to solve the problem of EGFR TKI resistance in lung cancer. In fact, Tabrecta is conducting clinical trials in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Patients with EGFR mutated non-small cell lung cancer with T790M negative and MET gene amplification during treatment with 1st and 2nd generations EGFR TKI or Tagrisso were targeted The combination therapy of Tabrecta and Tagrisso is compared with platinum-based chemotherapy. Han Ji-yeon, a professor of hematologic oncology at the National Cancer Center, said, "It is very important that MET gene number has been identified as prognostic factors. It is very meaningful that drugs such as Tabrecta, which proved a clear effect only on the MET Exxon 14 defect mutation, were approved." Janssen Korea is also in the process of registering the MET inhibitor Rybrevant, but failed to pass the committee last month.
