- LOGIN
- MemberShip
- 2026-05-07 18:03:06
- Company
- CMV treatment Livtencity can be prescribed at general hosp
- by Eo, Yun-Ho Oct 24, 2023 05:21am
- The cytomegalovirus treatment ‘Livtencity’ can now be prescribed at general hospitals in Korea. According to industry sources, Takeda Pharmaceuticals Korea’s Livtencity has passed the Drug Committees (DCs) of tertiary hospitals in Korea including Samsung Medical Center, Saint Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions such as the Kyungpook National University Hospital, Jeonbuk National University Hospital, and Chonnam National University Hwasun Hospital. Cytomegalovirus (CMV) is a type of herpes virus that's extremely common worldwide. Over 60% of all adults are infected with CMV within their lifetime and typically develops in patients who use immunosuppressants after hematopoietic stem cell transplantation (HSCT). Around 30-70% of HSCT patients experience CMV viremia. In HSCT patients, CMV causes multisystemic diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, pneumonia’s mortality rate is near 60%. Because CMV in immunocompromised patients is fatal, patients had generally received preemptive treatment mainly with ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization had been essential. Additionally, because these drugs have similar mechanisms of action if resistance to one drug develops, it is highly likely that the patient will not respond to other treatments as well. However, the introduction of Livtencity brings hope to these patients for secondary treatment. Livtencity has almost no side effects compared to existing drugs and offers an alternative if resistance to the existing treatments develops. Livtencity’s antiviral activity inhibits CMV multiplication and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells, but also interferes with viral DNA replication, encapsidation, and nuclear egress. Meanwhile, Livtencity was first approved in November 2021 by the US FDA as the first treatment for patients with post-transplant CMV infection/disease and was approved in Korea in December last year.
- Policy
- TZD combined DPP4i-SGLT2i complex
- by Lee, Tak-Sun Oct 24, 2023 05:21am
- Due to the expansion of the reimbursement standards for combination diabetes drugs, combination drugs combining TZD-based ingredients with DPP4i or SGLT2i are expected to be released in November. Most of these products are combination drugs combining the DPP4i series Sitagliptin. According to the industry on the 23rd, TZD combination drugs such as Mothers Pharmaceuticals Sitadion, Hyundai Pharmaceuticals Sitapio, Samik Pharmaceuticals Piosita, Medica Korea Pioglsita, Hutex Pharmaceuticals Piovia, Daewoo Pharmaceuticals Sita-Act, Jinyang Pharmaceuticals Januacto, and Daewon Pharmaceuticals Janupio will be listed on the payroll next month. These products are a combination of DPP4i-type Sitagliptin and TZD-type Pioglitazone. Boryung Trubuddy is also listed on the payroll. This drug is a combination of the SGLT2i series Dapagliflozin and Pioglitazone. The sudden emergence of Pioglitazone combination drugs is due to the expanded diabetes drug combination reimbursement standards last April and the impact of Sitagliptin with the patent expired in September. Last April, the combination of metformin + SGLT2i + TZD was approved for reimbursement. Accordingly, in the case of Boryung Trubuddy, which will be released in November, reimbursement is recognized when used together with metformin. The substance patent for Forxiga, the original product of dapagliflozin contained in Trubuddy, also expired on April 8. As the substance patent for Januvia expired on September 1, not only single drugs but also combination drugs are being released one after another. The Sitagliptin + Pioglitazone combination, which is being newly introduced this time, is the first combination drug developed quickly by domestic companies. These combination drugs have the advantage of reducing the risk of side effects and maximizing efficacy because each single drug has a different mechanism.
- Company
- Next-generation antibiotic Zavicefta can be prescribed
- by Eo, Yun-Ho Oct 23, 2023 05:14am
- The new antibiotic drug Zabicefta is entering the prescription range of general hospitals. According to related industries, Pfizer Pharmaceuticals Korea's Zavicefta is being used in tertiary general hospitals such as SMC, Seoul St. Mary's Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital, as well as Gangnam Severance Hospital, Korea University Guro Hospital, Korea University Ansan Hospital, National Cancer Center, and Ewha Womans University Mokdong Hospital. It has passed the Drug Committee (DC) of 39 medical institutions across the country. Zavicefta was developed to respond to the urgent need for a new antibiotic for serious infections where drug resistance is a serious problem, such as multidrug-resistant Pseudomonas aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing enteric bacteria. This drug is administered intravenously and is intended for adult patients suffering from clAI patients, cUTI, ventilator HAP, and aerobic Gram-negative infections with limited treatment options. Zavicefta is a drug originally developed by AstraZeneca and was acquired by Pfizer through the acquisition of its antibiotics division in 2016. Meanwhile, securing new treatment alternatives for carbapenems is a global health issue announced by the World Health Organization. Multidrug-resistant Gram-negative bacteria are increasing worldwide and have recently become a serious problem in healthcare-related infections. In particular, the World Health Organization has designated carbapenem-resistant Pseudomonas aeruginosa as one of the highest-priority pathogens requiring research and development of new antibiotics. The domestic Pseudomonas aeruginosa resistance rate to carbapenems was 30.6%, the second highest among the surveyed countries after Greece, and ESBL (extended-spectrum beta-lactamases)-producing enteric bacteria are also showing resistance to cephalosporin antibiotics, which are effective against a wide range of gram-negative bacteria. Antibiotics currently available in Korea include MSD's antibacterial drug 'Zerbaxa' and Pfizer's antifungal drug Cresemba, but only Zerbaxa is covered.
- Company
- New anemia tablets offer increased options
- by Nho, Byung Chul Oct 23, 2023 05:14am
- Whether the introduction of tablet formulations that offer improved convenience in intake in the KRW 100 billion renal anemia treatment market will shift the market paradigm and offer new options for anemia patients is gaining attention. Until now, erythropoietin stimulating agents were the mainstream treatment for anemia caused by chronic kidney disease, but in 2021, 2022, 2023, AstraZeneca·JW Pharmaceutical·Mitsubishi Tanabe Pharma Korea each received approval for their Evrenzo Tab(Roxadustat)· Enaroy Tab(Enarodustat)· Vadanem Tab(Vadadustat) from the Ministry of Food and Drug Safety, respectively, and showed the new potential held by hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI). According to drug distribution data, the size of Korea’s domestic renal anemia treatment market is around KRW 100 billion, and the same market is worth KRW 10 trillion in overseas markets where HIF-PHI is also prescribed Evrenzo, which was approved in Korea in 2021, can be administered to patients regardless of dialysis status to treat symptomatic anemia in patients with chronic kidney disease. Patients can benefit from its use as switching from ESA agents is allowed. Evrenzo activates the hypoxia-inducible factor (HIF), which regulates gene expression by regulating the formation of red blood cells. It targets the HIF and reversibly inhibits HIF-proline hydroxylase (HIF-PH). This stimulates the natural response that normally occurs when oxygen levels are low, including the production of erythropoietin and hemoglobin, reducing the symptoms of anemia. Its high efficacy has been confirmed in three clinical trials (ANDES, OLYMPUS, ALPS), and the trials confirmed that the drug can maintain hemoglobin concentration in patients who switch from ESA therapy. The drug, which was co-developed by AstraZeneca and FibroGen, was first approved in China in December 2018 and was approved in Japan the following year. JW Pharmaceutical’s Vadanem which was approved in 2022 is indicated for the treatment of adult patients with chronic kidney disease who are receiving hemodialysis. It is a HIF-PH inhibitor that stimulates ‘erythropoietin,’ a hormone that promotes the production of red blood cells while reducing ‘hepcidin,’ which regulates iron metabolism to improve the patient’s hemoglobin level. Unlike existing injections, it was developed as an oral formulation and is offered in 3 doses-1 mg, 2 mg, and 4 mg - improving the convenience of intake for the patients. In 2016, JW Pharmaceutical signed a licensing agreement with the Japanese company Japan Tobacco for the domestic development and distribution rights of 'JTZ-951', a new drug candidate for anemia of CKD. Afterward, the efficacy and safety of JTZ-951 were proven through Phase III bridging trials at 28 domestic hospitals. The trial confirmed the candidate’s non-inferiority to the existing treatment. ‘darbepoetin alfa.’ Mitsubishi Tanabe Pharma Korea’s new anemia treatment for patients with chronic kidney disease, Vadanem, was also approved by the Ministry of Food and Drug Safety in March this year. This drug is also indicated as a treatment for adult patients with chronic kidney disease who are receiving hemodialysis. It promotes red blood cell production by inhibiting proline hydroxylase, which degrades hypoxia-inducible factor (HIF). At the time of its approval, the Ministry of Food and Drug Safety, said, “The MFDS will continue being committed to the rapid provision of safe and effective treatment for the Korean people based on its expertise in regulatory science.” Evrenzo Tab, Enaroy, and Vadanem are all tablet (pill) formulations that offer significantly improved convenience over existing injection formulations. They are evaluated to be highly cost-effective in treating patients. Meanwhile, renal anemia is a common complication in patients with kidney disease that is caused by abnormal kidney function. The kidneys secrete erythropoietin (EPO), a hormone that promotes the production and maturation of red blood cells and helps the bone marrow that facilitate the production of red blood cells. However, when EPO production capacity decreases along with kidney function decline, hematopoiesis decreases, leading to anemia. Renal anemia reduces the patient's activity as it reduces energy production in organs due to a lack of red blood cells and lack of oxygen supply. It is also accompanied by fatigue, loss of appetite, decreased exercise ability, insomnia, and depression, lowering the quality of life and also affecting the patient's mortality rate. Currently, there are more than 700 million people with chronic kidney disease around the world, and 1 in 7 are known to suffer from anemia. Since it takes a long time for the symptoms of renal anemia to appear, many patients are known to lack awareness of their condition.
- Company
- Forxiga generics take over 30% of market in 6 mths
- by Kim, Jin-Gu Oct 23, 2023 05:14am
- Generic versions of ‘Forxiga (dapagliflozin)’ have increased their share in the market to 30% in half a year since the original Forxiga’s patent expiry. Since April of last year, 63 companies have been fiercely competing in the market after concurrently releasing their respective generic versions, and Boryung Pharmaceutical, Hanmi Pharm, Aju Pharm, Kyung Dong Pharma, and Daewon Pharmaceutical have recorded cumulative prescriptions worth more than KRW 1 billion in Q2 and Q3. On the other hand, 50 (79%) of the 63 companies that released generics posted cumulative prescriptions of less than KRW 300 million. Forxiga market increases from KRW 24.9 bil to KRW 35.8 bil…share of generic drugs increase to 30% According to the market research institution UBIST on the 21st, the volume of outpatient prescriptions for dapagliflozin single-agent drug and metformin combinations as of Q3 amounted to KRW 35.8 billion. This is a 44% increase in one year compared to KRW 24.9 billion it had made in Q3 last year. The analysis is that the large number of generics that joined the market drove the market expansion. The combined prescription performance of Forxiga and Xigduo generics in Q3 amounted to KRW 10.6 billion. Their share reached 30%. In just half a year after the generic drugs entered in bulk, their market share has increased to 30%. The generic companies have poured out products since Foxiga’s patent expiry in April. A total of 90 companies have received approval for their generic versions of Forxiga and Xigduo, 63 of which have released their products. The generic drugs have rapidly expanded their share in the market following their release. In Q2 last year, about 60 companies accounted for 18% of the market share with a combined prescription amount of KRW 5.9 billion. The companies then increased their market share to 30% in 3 months. Quarterly presriptions of Forxiga and Xigduo In particular, the penetration of generic drugs in the single-agent market is fast. In Q3, the original Forxiga recorded prescription sales of KRW 13.7 billion and generic drugs of KRW 6.8 billion in cumulative sales. The market share is around 33%. Generics accounted for one-third of the market within half a year of launch. In the case of combination drugs, original drugs recorded KRW 11.6 billion and generic drugs recorded KRW 3.8 billion. The proportion of market share is 75% to 25%. #SB Boryung and Hanmi’s cumulative prescriptions account for over KRW 2 billion... 50 out of 63 places earn less than KRW 300 million Amid fierce competition between generic companies, Boryung and Hanmi Pharmaceuticals achieved cumulative sales of more than KRW 2 billion. Boryung recorded KRW 2.3 billion in Q2 and Q3 with its single-agent drug Trudapa and its Trudapa+metformin combination TrudapaM. Hanmi Pharm recorded prescription sales of KRW 2.1 billion with its Dapalon and Dapalon Duo. Aju Pharm, Kyung Dong Pharma, and Daewon Pharmaceutical also recorded prescriptions of over KRW 1 billion in Q2 and Q3 combined. Aju posted sales of KRW 1.4 billion, Kyung Dong Pharma KRW 1.3 billion, and Daewon Pharmaceutical KRW 1.1 billion. However, with so many companies entering the competition at the same time, most companies showed performance that was below expectations. Among the 64 companies that released their respective products, 50 companies' cumulative prescription performance in Q2 and Q3 was less than KRW 300 million. This means that 4 out of 5 (79%) distributors of Forxiga generics are having difficulties in this market. The average prescription amount per generic company in Q2 and Q3 only amounted to KRW 260 million. Original Forxiga and Xigduo fare well despite generic entry…prescriptions rise 2% YoY The original Forxiga and Xigduo have also achieved not bad results. Rather, the total prescriptions for the two products combined amounted to KRW 25.3 billion, up 2% YoY. Forxiga recorded prescription sales of KRW 13.7 billion in Q3. Compared to Q3 last year (KRW 13.1 billion), prescriptions increased by 4%. In the case of Xigduo, prescriptions amounted to KRW 11.6 billion. No significant change has been made compared to Q3 last year (KRW 11.7 billion). Industry evaluation is that the original drugs are faring well considering the aggressive expansion of generic drugs in the market. AstraZeneca, the company that manufactured the original drug, had postponed the drug price reduction that was applied following the release of generics through administrative litigation. AstraZeneca filed an administrative suit against the Ministry of Health and Welfare's ex officio adjustment of insurance ceiling prices because Forxiga’s indications are not only for diabetes but also for heart failure. At the same time, an application for suspension of execution was filed to postpone the disposition until the conclusion of the main lawsuit. The court accepted this request, and the drug price cut for Forxiga and Xigduo was postponed until February of next year.
- Company
- Reimb pricing negotiations for Luxturna start in KOR
- by Eo, Yun-Ho Oct 23, 2023 05:14am
- The one-shot retinal dystrophy treatment ‘Luxturna’ has entered its last stage to reimbrursement in Korea. According to industry sources, Novartis Korea recently entered drug pricing negotiations for its Inherited Retinal Dystrophy (IRD) treatment Luxturna (voretigene neparvovec) with the National Health Insurance Service. Luxturna passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review on September 7th. The company had applied for reimbursement of its drug in September 2021, but no progress had been made at the time. In March, Luxturna failed to pass the Drug Reimbursement Evaluation Committee review and set reimbursement standards. The company had supplemented and reapplied for the drug’s reimbursement, thanks to which the company was able to start reimbursement negotiations. The government and company had been unable to reach an agreement in Luxturna's evaluation process due to differences in opinion regarding the terms of the Risk Sharing Agreement (RSA) (refund type, etc.). In this situation, Novartis has submitted supplementary data to apply again for reimbursement, and both the government and pharmaceutical companies have shown a strong will to reimburse the drug in Korea. Therefore, it remains to be seen whether the drug price negotiations can be completed. By replacing the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene, Luxturna restores the visual function of an IRD patient with a single administration. In other words, the drug provides a fundamental cure for IRD. In the US, the drug was granted a Breakthrough Therapy Designation by the FDA in 2014, the drug was approved as an orphan drug in 2016, then was granted Priority Review and a Fast-Track designation in 2017. Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, 1.6 points higher than the 0.2 points in the control group.
- Company
- The DPP4i+SGLT2i diabetes combination drug market
- by Kim, Jin-Gu Oct 23, 2023 05:14am
- Qtern>Zemidapa> Esgliteo, Sugadapa product photo (clockwise from top left) The market for diabetes two-drug combination drugs that combine DPP-4 inhibitors and SGLT-2 inhibitors appears to be growing slowly despite the expansion of combination benefits at the beginning of the year. Since last May, two-ingredient combination drugs have appeared on the market one after another, but the cumulative prescriptions for related products in the five months until last September amounted to only 3.6 billion won. The pharmaceutical industry is paying attention to the possibility that the market will expand, focusing on generic drugs, as the combination drug of dapagliflozin + sitagliptin has been released since the Januvia patent expired in September. The cumulative prescription amount for 5 months: Qtern 1.1 billion won > Zemidapa 1 billion won > Esgliteo 800 million won. According to UBIST, a pharmaceutical market research firm, on the 23rd, the cumulative prescription amount for the two-drug combination of DPP-4 inhibitor and SGLT-2 inhibitor is 3.6 billion won. This market was formed last May with the launch of LG Chemical's Zemidapa, AstraZeneca's Qtern, Boehringer Ingelheim's Esgliteo, MSD's Stegluzan, and Chong Kun Dang's Exiglu-S. In June, Donga ST Sugadapa joined. These are all companies that possess original drugs in the DPP-4 inhibitor series. They began releasing related products last April when the health authorities expanded the combination coverage of diabetes treatments to the 'DPP-4 inhibitor + SGLT-2 inhibitor + Metformin' triple therapy. At that time, the patent for Forxiga, an SGLT-2 inhibitor type diabetes treatment, expired. They developed and released a combination drug by combining their original DPP-4 inhibitor drug with Dapagliflozin or their own SLGT-2 inhibitor drug. In the case of Chong Kun Dang, as it was about to acquire the domestic distribution rights to Januvia from MSD, it was able to release a combination drug of sitagliptin and Dapagliflozin before Januvia's patent expired. Despite the expansion of concurrent benefits, the related market appears to be growing slowly. By month, it is 300 million won in May, 400 million won in June, 600 million won in July, 900 million won in August, and 1.3 billion won in September. Based on the cumulative prescription amount, AstraZeneca Qtern is the highest at 1.1 billion won, followed by LG Chem's Zemidapa (1 billion won), Boehringer Ingelheim's Esgliteo ( 800 million won), Chong Kun Dang's 'Exiglu-S' ( 300 million won), and Dong-A ST's Sugadapa (200 million won ), etc. After Januvia’s patent expires in September, generics enter the market… Will there be a turnaround after the fourth quarter? In the pharmaceutical industry, as DPP-4 inhibitors and SGLT-2 inhibitors have shown high prescription performance in the existing diabetes treatment market, predictions have been raised that combination drugs combining the two ingredients will also rapidly expand the market size. Looking only at prescription performance through the third quarter, it is evaluated that the performance is somewhat below expectations. In fact, the prescription performance of dapagliflozin expanded very rapidly during this period. In the case of dapagliflozin single drug, prescription sales amounted to 20.5 billion won in the third quarter of this year. Compared to the third quarter of last year, it increased by 47% in one year. The price of the Dapagliflozin + Metformin combination increased by 31% from 11.7 billion won to 15.3 billion won during the same period. The key is the prescription performance after the fourth quarter when many combination drugs of dapagliflozin and sitagliptin will be released. This is because, with the expiration of Januvia's patent last month, combination drugs combining the two ingredients are entering the market one after another. According to the Ministry of Food and Drug Safety, to date, 89 pharmaceutical companies have received approval for two-ingredient combination drugs. Among these, 14 pharmaceutical companies released products last September, excluding Chong Kun Dang, which holds the distribution rights to Januvia. Many of the remaining 80 pharmaceutical companies are expected to release products after the fourth quarter.
- Policy
- Announcement of dual pricing system
- by Lee, Jeong-Hwan Oct 20, 2023 05:32am
- The Ministry of Health and Welfare is expected to include the application of a refund-type risk-sharing system for innovative new drugs in the plan to provide appropriate information on the innovative value of new drugs to be announced soon. In order to improve accessibility to rare disease treatments, the company announced its position to carefully review the plan to expand the scope of drugs from children to adults by omitting the submission of economic evaluation data. In the case of reimbursement management for expensive new drugs, we plan to implement policies to minimize uncertainty in financial impact by applying a patient-based performance-based reimbursement system, implementing a prior approval system, and setting standards for discontinuation of medication. On the 19th, the Ministry of Health and Welfare responded as follows to a written inquiry from People Power Party lawmaker Lee Jong-seong on the government audit. ◆Application of the dual pricing system = Regarding the expansion of the refund-type risk-sharing system to prevent Korea from passing and promote the overseas expansion of domestically developed new drugs, the Ministry of Health and Welfare said, "We are reviewing a plan to improve the drug price system to appropriately compensate for the innovative value of new drugs." We also agreed on the need to ensure profitability and support the overseas export of R&D-invested new drugs, such as conducting domestic clinical trials. In particular, they announced that they will prepare appropriate measures, including the application of a risk-sharing system (dual pricing system), to the extent that they do not conflict with WTO trade issues in order to promote the overseas expansion of domestically produced new drugs and strengthen price competitiveness. ◆ Expansion of drugs subject to PE data = In order to strengthen patient accessibility to new drugs for serious diseases such as cancer and rare diseases, the Ministry of Health and Welfare has revised related regulations since January of this year to allow for rapid listing of new drugs with a small number of patients and clinically proven to improve quality of life. He explained that he is operating it by adding it as a PE omission target. Crysvita, a new drug for the treatment of hypophosphataemic rickets in children, was administered on May 1, an example of rapid reimbursement due to a revised regulation. At the same time, the Ministry of Health and Welfare expressed its position that social discussion is needed regarding the expansion of drugs subject to PE omission to adults and that it should be pursued with caution. It should be taken into account that the PE omission system is an exceptional operation in which the cost-effectiveness evaluation is determined based on the listed price of the excluded country. ◆Improvement of the orphan drug coverage rate = In relation to the improvement of the orphan drug coverage rate, the Ministry of Health and Welfare aims to strengthen coverage of treatments for expensive severe diseases and has launched two items to treat rare pediatric diseases with a life expectancy of less than one year, no alternative drugs, and sufficient improvement effect. They announced that they are conducting a pilot project to simultaneously conduct the Ministry of Food and Drug Safety approval evaluation, HIRA reimbursement evaluation, and NHIS drug price negotiation in the second half of this year. It was announced that reimbursement management would be strengthened by applying a patient-based performance-based reimbursement system for high-priced new drugs, implementing a prior approval system, and setting standards for discontinuation of medication to minimize uncertainty about financial impact.
- Company
- LG Chem-BR Pharm signs MOU for HP Vitaran in CHN
- by Lee, Seok-Jun Oct 20, 2023 05:31am
- On the 19th, LG Chem announced it had signed a Memorandum of understanding (MOU) with BR Pharm, a regenerative medicine technology research and manufacturing company, for the development and approval of its PN (polynucleotide) skin booster 'HP Vitaran' in China. BR Pharm's 'Vitaran', which LG Chem introduced to the Korean market in September this year, is a PN skin booster medical device created from purified DNA extracted from the reproductive cells of salmon fish. PN suppresses cytokines that cause skin inflammation and promotes skin tissue regeneration by proliferating fibroblasts. In a clinical trial for 'Vitaran Eye' that involved 250 Koreans, the treatment significantly improved the wrinkles around the corners of the eyes. Hye-ja Kim, Vice President of LG Chem (head of the aesthetics division), said, "We are focusing on expanding market influence through direct sales in China. For this, we have established an aesthetics sales corporation in China in 2021. We seek to create differentiated customer value in China’s aesthetics market through this reinforced partnership with BR Pharm.” Seok-Sun Kim, CEO of BR Pharm, said, “We will accelerate our entry into the Chinese market based on the synergy between the company’s manufacturing competitiveness and LG Chem’s Chinese aesthetic business capabilities.”
- Company
- Gilead’s TNBC drug Trodelvy is released in KOR
- by Son, Hyung-Min Oct 20, 2023 05:31am
- Gilead Sciences Korea announced on the 18th that it has launched its metastatic triple-negative breast cancer drug ‘Trodelvy (sacituzumab govitecan)’ in Korea. Until now, Trodelvy has been supplied through the Korea Orphan & Essential Drug Center, but from the 18th, Gilead will supply it domestically, and patients will be able to use it with prescriptions at hospitals. Trodelvy, a Trop-2 targeting antibody-drug conjugate (ADC), consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and a TOP1 inhibitor payload ‘SN-38’ that destroys cancer cells. By targeting only Trop-2, which is highly expressed in various types of cancers, including more than 85% of breast cancers, the cytotoxic drug is delivered with minimal impact on normal cells. Trodelvy was approved by the Ministry of Food and Drug Safety in May for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Excluding cytotoxic anticancer drugs, Trodelvy is the only treatment approved by the MFDS for the entire patient population, regardless of genetic mutation or biomarker, as a second-line or higher treatment for patients with mTNBC. The National Comprehensive Cancer Network (NCCN) breast cancer treatment guidelines recommend Trodelvy as Category 1 for the second-line or higher lines of treatment of adult patients with metastatic triple-negative breast cancer. Jae-yeon Choi, General Manager of Gilead Sciences Korea, said, “We are pleased to provide Trodelvy, which has been shown to significantly improve survival in patients with metastatic triple-negative breast cancer, as a new treatment option for those who have been long waiting for an innovative treatment option. We will continue to protect the daily lives of our cancer patients in Korea, including those with triple-negative breast cancer, and strive to not only supply innovative treatments but to also increase disease awareness and improve the treatment environment.” Triple-negative breast cancer is a subtype of breast cancer that is clinically negative for the expression of estrogen and progesterone receptors (ER/PR) and HER2. It is known to be the most aggressive among breast cancers. It also has a poor prognosis due to its high risk of metastasis and recurrence compared to other subtypes and high risk of metastasis to the brain (30%) or lungs (40%). Its five-year survival rate is only 12%, compared to the 30% in other breast cancer types.
