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- 2026-05-09 09:58:30
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- Imbruvica fails CDDC twice and reattempts 1st-line reimb.
- by Eo, Yun-Ho Apr 05, 2022 05:59am
- Once again, the blood cancer drug ‘Imbruvica’ is attempting to expand reimbursement to first-line treatment. According to industry sources, Janssen Korea has applied for the reimbursement extension of its Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) to once again attempt at deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Imbruvica’s first-line indication was unable to pass deliberation by the CDDC twice, one of which was held in October last year. The company 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. Therefore, how Janssen will progress discussions on reimbursement based on what adjustments remain to be seen. 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 CLL, ▲monotherapy for the treatment of adult patients over the age of 65 with previously untreated CLL, ▲in combination with obinutuzumab for the treatment of adult CLL patients over the age of 65 or those who have comorbidities or at high-risk and those under the age of 65 with previously untreated CLL. Meanwhile, CLL is a type of blood cancer that occurs mainly in adults over the age of 60, characterized by increased production of mature but dysfunctional B lymphocytes Around 120 to 130 patients are newly diagnosed with CLL every year, and 60-70% of the CLL patients in Korea are discovered in a state that does not require treatment. Like its name, this “chronic” condition progresses slowly, sometimes insignificantly for several years.
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- AZ starts next-gen ADC dev with confidence from Enhertu
- by Apr 04, 2022 06:07am
- AstraZeneca is leading the next-generation ADC development environment. The company, which has successfully commercialized ‘Enhertu’ in partnership with Daiichi Sankyo, is targeting areas slow in development such as triple-negative breast cancer. On the 31st, AstraZeneca received approval for its Phase III trial of a new ADC drug last month. The new ADC drug subject to the trial is ‘datopotamab deruxtecan (DS-1062, hereafter datopotamab),’ a TROP2 targeting ADC that is being co-developed by AstraZeneca and Daiichi Sankyo. The Phase III trial for datopotamab will be conducted on patients with unresectable locally advanced or metastatic triple-negative breast cancer. The trial will evaluate the drug’s efficacy as a first-line treatment in patients who are not eligible for treatment using PD-(L)1 immunotherapies in comparison to chemotherapy. MoA of datopotamab(Source: Daiichi Sankyo) ADC is a next-generation drug that is produced by coupling a potent cytotoxic agent to a monoclonal antibody that binds to a specific antigen on the surface of a tumor cell. It minimizes the side effects while increasing the treatment effect by selectively working on cancer cells. Although ‘Kadcyla’ marked the start of the commercialization of ADC drugs, the drugs were unable to make significant performance in the earlier stages due to technical limitations. Since then, the development of next-generation ADCs, such as linkers that control the drug-antibody ratio (DAR) or enhance blood stability, is being developed in earnest. AstraZeneca already has experience commercializing an HER-2 targeted ADC, ‘Enhertu’ after signing a joint development agreement with Daiichi Sankyo. Enhertu had demonstrated superior efficacy over the early-generation ADC drug ‘Kadcyla’ as a second-line treatment in HER2-positive breast cancer. According to results from the DESTINY-Breast03 that was presented last year, Enhertu reduced the risk of disease progression and deaths by 72% compared to Kadcyla in the head-to-head trial. Also, the objective response rate (ORR) was significantly higher, 80% in the Enhertu group as compared to 34% in the Kadcyla group. The new ADC therapy that will be presented by AstraZeneca will target the field of triple-negative breast cancer that has poor prognosis. In the Phase I trial, datopotamab showed positive results with an ORR of 43% and DCR of 95%. If significant results continue on in the follow-up trials, AstraZeneca’s new ADC will likely compete with Gilead’s ADC therapy. Like datopotamab, Gilead’s ADC drug ‘Trodelvy’ also targets TROP2. Trodelvy was approved by the US FDA as a treatment for triple-negative breast cancer last April. AstraZeneca paid Daiichi Sankyo $1 billion (₩1.22 trillion) in upfront payment for the development rights of datopotamab. AstraZeneca will pay additional conditional amounts up to $6 billion according to the company’s achievement of development and commercialization milestones. In the past, AstraZeneca had signed a $6.9 billion (₩8.41 trillion) agreement with Daiichi Sankyo for the development rights of Enhertu. The company is also investigating using datopotamab in combination with its immunotherapy ‘Imfinzi’ in addition to another trial that assesses the effect of datopotamab in NSCLC. In addition to the ADC technology the company had bought from other companies, AstraZeneca is also developing a next-generation ADC using its linker technology, 'AZD8205.’ 'AZD8205 is a new drug candidate that targets overexpression of B7-H4 found in various solid cancers. The company plans to first disclose study results for AZD8205 at the ‘AACR 2022’ that will be held from the 8th.
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- Keytruda, the primary treatment for esophageal cancer
- by Apr 04, 2022 06:07am
- Keytruda, an immuno-cancer drug of MSD, has become the primary option in esophageal cancer, where treatments have been limited. The medical team predicted that an immuno-cancer drug-oriented treatment strategy using Keytruda or Opdivo will be established depending on the PD-L1 expression rate. At a seminar to commemorate the expansion of Keytruda indications held online by MSD Korea on the 31st, Sun Jong-moo, a professor of hematological oncology at Samsung Medical Center, pointed out the meaning of the launch of Keytruda in esophageal cancer. He said, "As immuno-cancer drugs appear in esophageal cancer, treatment strategies are changing in the direction of considering using immuno-cancer drugs from the earliest stage possible depending on the PD-L1 expression rate of patients." Professor Sun Jong-moo of the Dept. of Hematology at SMC, who is presenting at the MSD Online Seminar in KoreaOn the 7th, the MFDS expanded indications for Keytruda in combination with chemotherapy in metastatic esophageal cancer and gastroesophageal junction cancer, which cannot be operated. Keytruda is the first immuno-cancer drug to be released in the primary treatment. Keytruda targets patients with positive PD-L1 expression. Esophageal cancer is largely divided into squamous epithelial cell cancer and adenocarcinoma, of which squamous epithelial cell cancer accounts for 90%. According to Professor Sun, esophageal cancer is considered a very difficult cancer, and if surgery is impossible, it should be treated with chemotherapy. However, when chemotherapy is used, mOS is only about 10 months. Although treatments have developed dramatically in various cancers over the past decade, esophageal cancer has continued for nearly 40 years. Keytruda significantly improved the therapeutic effect through a study on KEYNOTE-590, a licensed clinical trial. The mOS of Keytruda+anti-cancer chemotherapy group was 13.5 months, which was significantly longer than the control group (anti-cancer chemotherapy alone) of 5.5 months. Keytruda reduced the risk of death by 38%. mPFS also reduced the risk of disease progression or death by 49% compared to 5.5 months in the control group to 7.5 months in the Keytruda group. Keytruda previously put forward a distinctly different strategy from BMS's immuno-cancer drug Opdivo, which entered esophageal cancer. Opdivo can be used regardless of the PD-L1 expression rate, but can be used as a secondary treatment in patients who first used chemotherapy. Conversely, Keytruda was limited to PD-L1 positive patients, but acquired the status of primary treatment. Professor Sun said, "The current treatment that can be used in the primary esophageal cancer is a drug that has been used since the early 80s, and the demand for unmet was high." Professor Sun said, "Now that immuno-cancer drugs can be used in the first round, the treatment effect is expected to increase significantly," adding, "Medical staff also experienced that adding immuno-cancer drugs to chemotherapy does not significantly increase side effects, and the experience has been proven by clinical data."
- Company
- Export of Celltrion/Samsung bioepis exceed ₩10trillion
- by Chon, Seung-Hyun Apr 03, 2022 04:18pm
- According to the Financial Supervisory Service on the 1st, four biosimilars, Celltrion Healthcare's Remsima, Truxima, Herzuma and Remsima SC, recorded a total of 1.5694 trillion won in exports last year. It fell 2.0% from 1.616 trillion won in 2020, but exceeded 1 trillion won for the third consecutive year from 2019. Celltrion Healthcare is an affiliate of Celltrion, and Celltrion Healthcare Holdings is the largest shareholder (24.3% stake). Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global retailers. Celltrion Healthcare sells four biosimilars, Remsima, Truxima, Herzuma and Remsima SC, in overseas markets. Remsima's original drug is Janssen's Remicade. Remsima SC is Remsima's injection formulation. Truxima and Herzuma are biosimilars from Mabthera and Herceptin, respectively. According to last year's export performance by item, Remsima recorded the largest export amount of 809.6 billion won. It recorded the highest export performance ever, up 31.1% from 617.4 billion won in 2020. Remsima SC exported 89.6 billion won last year, up 157.3% from the previous year. Remsima and Remsima SC collaborated on a total of 899.2 billion won in exports last year. Remsima is the first biosimilar product approved in 2012. Remsima recorded the largest export of Celltrion's biosimilars every year, with Truxima leading the way with 786.8 billion won in 2019. However, Remsima beat Truxima last year, re-establishing its lead in exports. Truxima's exports amounted to 459.1 billion won last year, down 41.6% from the previous year. The company explains that sales have decreased due to temporary supply schedule adjustments. Celltrion Healthcare started selling Truxima in the U.S. in 2020. At this time, Truxima's supply decreased relatively last year as U.S. sales partners supplied a large amount of Truxima's launch volume. It is analyzed that growth has slowed down somewhat as competition for biosimilars intensified. Truxima had a 25% prescription share of the U.S. market in the fourth quarter of last year. Truxima had a 34% share of the European market as of the third quarter of last year. Herzuma's exports amounted to 211 billion won last year, up 29.8% from the previous year. Herzuma took the lead in the Japanese market with a 51% share as of the third quarter of last year. However, the European market has slowed down recently. Herzuma had a 19% market share in Europe in the first quarter of 2020, but fell to 13% in the third quarter of last year. Celltrion Healthcare, which was listed on the KOSDAQ market in 2017, has listed its export performance in its business report since 2014. Remsima and Remsima SC recorded the largest export performance of 4.2742 trillion won since 2014. Truxima, which has had export performance since 2017, posted 2.1783 trillion won in cumulative exports, while Herzuma's cumulative exports amounted to 693.9 billion won. Celltrion Healthcare's export performance of four biosimilars recorded last year since 2014 totaled 7.16 trillion won. Samsung Bioepis has also set a new sales record every year since 2016. Samsung Bioepis posted 847 billion won in sales last year, up 9.0% from the previous year. It is the largest since the company was established in 2012. It has continued to grow recently, increasing 129.7% in three years from 368.7 billion won in 2018. Annual Celltrion Healthcare biosimilar exports (unit: 1 million won, data: Financial Supervisory Service) Most of Samsung Bioepis sales occur through overseas sales of its own biosimilar products. Samsung Bioepis succeeded in commercializing biosimilar products of six biopharmaceuticals, including Enbrel, Remicade, Herceptin, HUMIRA, Avastin, and Lucentis. In Europe, all six products have been licensed, and in the United States, five products have been approved for sale except Avastin. Since Samsung Bioepis recorded sales of 765.9 billion won in 2019, its growth rate was only 1.5 % the following year. In the early days of the COVID-19 crisis, the number of drug prescriptions decreased, resulting in a temporary market reduction. Quarterly performance fluctuated as pre-orders from hospitals and wholesalers in Europe occurred with the aim of securing inventory in preparation for the prolonged COVID-19. However, it recovered its growth last year due to the expansion of biosimilar sales in the U.S. and Europe. Samsung Bioepis' biosimilars are sold overseas by its partners Biogen and Organon. Biogen will sell three types of biosimilars for autoimmune disease treatments: Enbrel, Remicade, and Humira in Europe. Organon sells these three products in the rest of the world except Europe and South Korea. In the United States, only Remicade biosimilars are sold. Organon is also responsible for overseas sales of two types of biosimilars, Herceptin and Avastin. The company's five biosimilars recorded a total of $1.255.1 billion (about 1.5 trillion won) in overseas markets last year. It achieved its highest sales, up 11% from $1.125.8 billion in 2020. Sales of biosimilars sold by Biogen reached 831.1 million dollars last year, up 4% from the previous year. Organon sales rose 28% year-on-year to 424 million dollars. Founded in 2012, Samsung Bioepis generated 43.7 billion won in sales for the first time in 2013. In 2016, sales recorded 147.5 billion won as the overseas expansion of biosimilars began in earnest, and has continued to grow every year since then. Samsung Bioepis has recorded cumulative sales of 3.3649 trillion won since its launch in 2012. Most of Samsung Bioepis' sales come from overseas sales of biosimilars or profits from technology fees. Domestic sales are insignificant. According to IQVIA, a pharmaceutical research firm, Samsung Bioepis' sales of five biosimilars totaled only 13.2 billion won last year. Celltrion and Samsung Bioepis biosimilars have collaborated on exports of a total of more than 10 trillion won.
- Company
- MS anticancer drug Revlimid, RVD combined therapy benefits
- by Nho, Byung Chul Apr 03, 2022 04:13pm
- BMS Pharmaceutical Korea announced on the 30th that Revlimid (Renalidomide) will be subject to benefits when administered in combination with Bortezomib/Dexamethasone, which is used to treat multiple myeloma patients, from the 1st of next month. The law has proven its superior effectiveness and tolerance compared to current standard treatment through several clinical studies. Random allocation, public labeling, and phase 3 clinical trials (SWOG0777) in newly diagnosed patients with multiple myeloma confirmed significant progression-free survival and overall survival improvement compared to conventional RD (Revlimid+dexamethasone) therapy. The median progression-free survival period of the RVD therapy group was 41.7 months, 12 months longer than the 29.7 months of the RD therapy group, and the overall OS median was also statistically significantly improved from 69 months of the RD therapy group. The objective response rate was also significantly higher in the RVD therapy group (82.9%) than in the RD therapy group (72.5%), confirming its clinical usefulness. Even in newly diagnosed patients with polymyeloma with transplantation, RVD therapy showed a higher response rate and deeper response with treatment progress than the current standard therapy VTD (Vortezomib+Thalidomide+Dexamethasone). According to an integrated analysis of four phase 3 randomized control clinical trials, RVD studies (GEM2012, IFM2009) and VTD studies (GEM2005, IFM 2013-04), in comparison between GEM studies, RVD induction therapy confirmed a very good Partial Remission adverse response rate compared to VTD induction therapy. The response rate of very good partial response (VGPR) abnormalities gradually increased, showing 54.5% after three-cycle induction therapy and 70.1% after six-cycle induction therapy, which was significantly higher than VTD therapy throughout the treatment. The results of comparison between GEM studies also showed a higher response rate of VGPR abnormalities and a higher negative rate of Minimal Residual Disease (MRD) after transplantation with higher RVD therapy. As a result of the RVD study (GEM2012), the complete response at the end of induction therapy was similar to 34.8% in all patients (458 and 33.4%) and in the cytogenetic high-risk group (92), proving that it can be used regardless of whether it is a cytogenetic risk group. RVD therapy is already the most recommended treatment abroad. The U.S. National Cancer Network (NCCN) Guidelines, released in 2022, recommends RVD therapy as "preferred regimen, category 1", the highest recommended level in both cases that can or cannot be transplanted when treating multiple myeloma. ESMO guidelines also recommend it as the first choice of therapy (1st option) in all patients with multiple myeloma that can or cannot autologous hematopoietic stem cell transplantation. In addition, Revlimid is subject to health insurance benefits when administered in combination with Rituximab in the treatment of previously treated follicular lymphoma (grade 1-3a). Expectations have been high for the application of RVD therapy benefits in the medical field. With the application of this benefits, RVD therapy is expected to become a standard treatment for primary treatment of multiple myeloma. Kim Jin-young, CEO of BMS Pharmaceutical Korea, said, "We are glad that Revlimid's coverage of insurance benefits allows patients with multiple myeloma and follicular lymph nodes to enjoy advanced treatment benefits as soon as possible."
- Company
- Revlimid's reimb extended…maintenance therapy remains
- by Eo, Yun-Ho Apr 01, 2022 06:04am
- The reimbursement standards for ‘Revlimid’ in combination with Velcade, and dexamethasone (RVD) for multiple myeloma have been extended. However, reimbursement for the drug as a maintenance therapy still remains unaddressed. Starting on April 1st, BMS Korea’s Revlimid (lenalidomide) will receive insurance benefits as part of RVd (lenalidomide+bortezomib+ dexamethasone) therapy. The approval was made 6 months after the agenda passed the meeting of the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service in September last year. However, the maintenance therapy agenda that was deliberated on the same day still remains non-reimbursed. BMS had started the listing process in 2019, but no progress has been made as of yet. Revlimid had been presented for deliberation at the Cancer Disease Deliberation Committee meeting in September that gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ to no avail. From the government’s perspective, there exist concerns on whether they should allocate NHI finances on drugs taken as a sort of ‘preventive measure’ after a patient’s condition has improved. In some parts, the government’s concerns may seem just. Revlimid maintenance therapy is used in patients post-autologous hematopoietic stem cell transplantation However, the agenda still deserves consideration. The progression-free survival of the patients that was demonstrated with the use of Revlimid maintenance therapy was 52.8 months, compared to the 23.5 months of the placebo group. This is a twofold difference. Based on the study data, patients who do not receive maintenance therapy after transplantation are required to start second-line therapy much faster. The three-drug combinations used as second-line with Revlimid such as Kyprolis, Empliciti, Ninlaro, and Daralex are relatively high priced. Therefore, delaying the time to relapse through the use of Revlimid as monotherapy may have the effect of delaying the use of the high-priced three-drug combo. In addition, Revlimid’s price has been discounted after its patent expiry, and the price will be further reduced if the reimbursement is extended to maintenance therapy. Hyeon-Seok Eom, Head of the Center for Hematologic Malignancy at the National Cancer Center Korea, said, “It goes without saying that maintenance therapy is important as it prolongs survival and improves the patients’ quality of life. We need to reduce the burden of treatment costs for our patients in Korea as soon as possible by expanding coverage of Revlimid as maintenance therapy in multiple myeloma as it is a well-established option that demonstrated its efficacy through a large-scale clinical trial.”
- Company
- Roche joins in competition for RET-targeted therapies
- by Apr 01, 2022 06:03am
- Following Lilly, Roche has also received approval for its RET targeted anticancer therapy. The entrance of two drugs in a similar period is expected to spark new competition in the RET-targeted therapy market. On the 29th, Roche received marketing authorization for ‘Gavreto (pralsetinib) from the Ministry of Food and Drug Safety. Its first indications are for non-small cell lung cancer and thyroid cancer. More specifically, Gavreto was approved for the treatment of adult patients with RET fusion-positive locally advanced or metastatic NSCLC, and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer that require systemic therapy. Gavreto is the second RET-targeted therapy to be introduced to Korea following Retevmo. Retevmo (selpercatinib), which was developed by Lilly, received MFDS approval on the 11th. The two drugs have virtually landed at the same time in Korea. By indication, Retevmo’s indication is a bit broader. Compared to Gavreto, whose prescription was limited to adult patients, Retevmo may be used in patients over 12 years of age with medullary thyroid cancer. Also, Retevmo has an additional indication for RET fusion-positive thyroid cancer. The two drugs also show a difference in their form of administration. Retevmo is taken orally two times a day and may be taken with or without food as long as it is not co-administered with PPIs. If the drug needs to be taken with antacids such as PPI or H2 receptor antagonists, Retevmo should be taken after a certain period. On the other hand, Gavreto can be taken orally only once a day. However, food intake is prohibited 2 hours before administration and at least an hour after administration. In the LIBRETTO-001 that was the basis of Retevmo’s approval, the ORR of the Retevmo-treated group in patients with RET fusion-positive NSCLC without platinum-based treatment experience was 85%, and 79% showed a continued response. In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months. 10 of the 11 patients had shown objective CNS response for the brain metastasis that around half of the patients experience. Major adverse events included increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased blood sugar (glucose), decreased leukocytes, decreased albumin, and high blood pressure. In patients with medullary thyroid cancer, the treatment-naïve patients showed a response rate of 73%, and those with experience 69%. The response rate of Retevmo in RET fusion-positive thyroid cancer was 79%. In the ARROW trial, which became the basis of Gavreto’s approval, Gavreto showed an ORR of 70% in treatment-naïve NSCLC patients. Patients who have been previously treated with platinum-based chemotherapy and those who received systemic therapy showed a 58% response. In RET-mutated locally advanced or metastatic medullary thyroid cancer, treatment-naïve patients recorded a response rate of 71%, and those with experience 60%. The major adverse events reported included neutropenia, anemia, and high blood pressure. Until now, only chemotherapy was available as an option for cancer patients with RET gene mutations. The introduction of Retevmo and Gavreto in the area is expected to dramatically improve the treatment environment. The scope of application of the drug is also wide. Oncogenic RET gene mutation is found not just in non-small cell lung cancer and thyroid cancer, but also in colorectal cancer, breast cancer, and pancreatic cancer. With the two drugs entering in a similar timeframe, the companies are expected to race to occupy a larger share of the pie. Lilly, which first received approval, has been showing more progress. The company has applied for Retevmo’s reimbursement through the approval-reimbursement linkage system. Lilly is also conducting a Phase III trial on patients with early-stage NSCLC for the use of Retevmo as adjuvant therapy after curative treatment (surgery or radiotherapy).
- Company
- Sandoz, launched a muscle relaxation antagonist with Ilsung
- by Mar 31, 2022 04:27pm
- Sandoz Korea announced on the 29th that it signed an exclusive sales partnership with Ilsung on the 28th with muscle relaxation antagonist Sandoz Sugammedex Sodium. According to the agreement, the two companies will start supplying and selling Sandoz Sugamadex on the 13th of next month. The two companies expected that Ilsung's sales know-how, with its superior quality of Sandoz Sugarmadex Sodium, would create synergy. Sandoz Sugarmadex is a muscle relaxation antagonist that was approved by the MFDS in January. It exhibits a reversal effect of neuromuscular blocking induced by Rocuronium or Vecuronium, a systemic anesthetic ingredient. Sandoz carried out the entire production process in Europe, from raw materials to finished products of Sandoz Sugammedex Sodium. The goal is to provide cost-effective treatment options with differentiated quality. As of last year, sales of muscle relaxation antagonists in Sugammedex Sodium ingredients amounted to 46 billion won, an average growth rate of about 19% over the past five years from 2017. Ahn Hee-kyung, CEO of Sandoz Korea, said, "Starting with Sandoz Sugarmadex Sodium, we will build a solid position based on the differentiated quality of Sandoz Korea in the anesthetic field in the future."
- Company
- First-ever RET inhibitor 'Retevmo' attempts reimbursement
- by Eo, Yun-Ho Mar 31, 2022 05:58am
- The first RET-targeted anticancer therapy is attempting to receive insurance reimbursement in Korea. According to industry sources, Lilly Korea has recently submitted a reimbursement application for its ‘Retevmo (selpercatinib) that targets the RET (Rearranged during transfection)-gene fusions. After receiving approval from the Ministry of Food and Drug Safety through the fast track system, the company has been making progress through the approval-reimbursement linkage system. In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation. Retevmo is indicated for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. Retevmo is expected to compete with Roche Korea’s ‘Gavreto (pralcetinib)’ in the future. Gavreto, which has the same mechanism of action as Retevmo, was approved in Korea on the 29th for the treatment of ▲ treat adult patients with RET fusion-positive locally advanced or metastatic NSCLC; and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer that require systemic therapy. Professor Byoung Chul Cho of the Yonsei Cancer Hospital’s Lung Cancer Center said, “We had no choice but to conduct chemotherapy in cancer patients with RET gene mutations due to lack of other available treatment options. The approval of Retevmo will become a good alternative for patients who saw relatively low treatment effect from existing chemotherapies and had difficulties due to chemotoxicity.” Meanwhile, Retevmo demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. Patients with RET fusion-positive NSCLC, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer patients with or without prior treatment experience were enrolled in the LIBRETTO-001 trial. The primary endpoints of the trial were the objective response rate (ORR) and duration of response (DOR) as assessed by the independent review committee In patients with RET fusion-positive NSCLC without platinum-based treatment experience, the ORR in the Retevmo-treated group was 85%. Although the median DoR was not yet reached, 79% of the patients showed duration of response during the follow-up period (median 7.4 months). In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.
- Company
- Kidney care is also important for diabetic patients
- by Eo, Yun-Ho Mar 30, 2022 06:09am
- SGLT-2 inhibitors, which have obtained indications for chronic kidney disease, are emerging as the mainstay of chronic disease management along with diabetes. According to data from the Korean Diabetes Association, the rate of kidney disease accompanied by type 2 diabetes patients in Korea was about 30%, and one in three diabetes patients in Korea had renal function abnormalities. Studies have also shown that diabetes (40%) is the most common cause of end-stage kidney disease. Diabetes patients have an average annual glomerular filtration rate (eGFR) decrease about twice as quickly as those without diabetes, and the 10-year neoplasia rate for diabetic patients is very low at 40%. Effectiveness of SGLT-2 inhibitors Forxiga, the first diabetic drug in the SGLT-2 inhibition mechanism to obtain an indication for chronic kidney disease, is also drawing attention from domestic medical staff. Forxiga confirmed the benefits of kidney disease in type 2 diabetic patients through a study of DECLARE-TIMI 58. In Forxiga of the DECLARE study, the secondary renal complex evaluation index (decreased by more than 40% eGFR, death from terminal kidney disease, kidney or cardiovascular disease) was 4.3% lower than placebo. The kidney subanalysis of the same clinical trial showed a continuous decrease in eGFR compared to placebo of less than 60 ml/min1.73 m2 by more than 40%, and a 47% reduction in the risk of death from terminal kidney disease or kidney disease. Forxiga confirmed benefits for patients with chronic kidney disease, regardless of diabetes. Jardiance is currently in the process of obtaining a kidney disease indication in the United States. This drug was confirmed to be effective through EMPA-KIDNEY research. The study will be discontinued early according to the recommendation of an independent data monitoring committee while meeting the criteria for positive efficacy. #Sb Society Guidelines also emphasize importance Several domestic and foreign societies first recommend SGLT-2 inhibitors to type 2 diabetes patients with chronic kidney disease in treatment guidelines, emphasizing the importance of integrated management of diabetes and kidney disease. The Korean Diabetes Association recommended that treatments including SGLT-2 inhibitors that have proven cardiovascular and kidney benefits should be considered first if albuminuria exists or the estimated glomerular filtration rate decreases in the 2021 Diabetes Care Guidelines. The American Diabetes Association recommended the use of SGLT-2 inhibitors that demonstrated benefits from heart failure or kidney disease in patients with heart failure or chronic kidney disease in the "2022 Diabetes Guidelines". The European Association for the Study of Diabetes and European Society of Cardiology also recommended SGLT-2 inhibitors as drugs to reduce the progression of diabetic nephropathy in the area of chronic kidney disease management in the "2019 Guidelines for Diabetes, Prediabetes and Cardiology". The KDIGO also recommended combination therapy with metformin and SGLT-2 inhibitors as the primary treatment along with lifestyle correction such as physical activity, diet, and weight loss in patients with chronic kidney disease with glomerular filtration rate of 30ml/min/1.73m2. Kim Dae Joong Professor of Endocrinology at Ajou University Hospital said, "In the long run, exposure to high blood sugar can cause glomerular damage, and proteinuria can occur from a relatively early stage in diabetic patients, so albumin excretion in urine should be measured annually. It is important to evaluate the glomerular filtration rate to determine the degree of abnormalities in new functions," he advised.
