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- 2026-06-28 06:18:11
- InterView
- CDK4/6 latecomer Kisqali exudes confidence in its effect
- by Jung, Sae-Im Apr 11, 2023 06:11am
- Novartis’s Kisqali (rivociclib), a latecomer CDK4/6 inhibitor used in metastatic breast cancer, is taking on an unexplored path, away from other CDK4/6 inhibitors. The drug has demonstrated efficacy in aggressive forms of breast cancer, which had not been attempted by other CDK 4/6 inhibitors. Aggressive breast cancers appear relatively often in Korea where the proportion of younger aged patients is large, but the patients’ only available option was to use highly toxic chemotherapy. In a recent interview with Dailypharm, Seock-Ah Im, Professor of Hemato-Oncology at Seoul National University Hospital said, “Younger breast cancer patients have a higher probability of accompanying visceral metastasis because of their rapid cancer growth and aggressive clinical pattern. However, due to the clinical practice guidelines that recommended using chemotherapy for the past 20 to 30 years, there were doubts about whether to use CDK4/6 inhibitors. However, Kisqali's recent study convinced me of the viability of using CDK4/6 therapies." The recent study mentioned by Professor Im is the RIGHT Choice trial that was released in December last year. The trial studied aggressive hormone receptor–positive, HER2-negative advanced breast cancer patients that had symptomatic visceral metastasis, rapid disease progression or impending visceral compromise, or marked symptomatic nonvisceral disease. Although the CDK4/6 inhibitor+ endocrine therapy is currently used as the standard treatment for breast cancer in the first line, chemotherapy was still used in patients with rapid disease progression or visceral metastasis. Metastatic breast cancer often spreads to the lungs, liver, or brain, and when metastasis occurs, symptoms such as shortness of breath and pain may arise. In such cases, it is difficult to quickly reduce tumor size with hormone therapy alone. CDK4/6 inhibitors have been introduced as a new option in this field, but no data existed demonstrating their effectiveness in these patients. Kisqali is the only CDK4/6 inhibitor class drug to demonstrate an improved effect over combined chemotherapy in aggressive breast cancer. Results showed that the median progression-free survival (PFS) of the Kisqali + endocrine therapy combination was 24.0 months, a 1-year extension over the 12.4 months recorded by the control group (HR=0.54). The median time to treatment failure in the Kisqali combination group was 18.6 months, which was at least 10 months longer than that of the control group (HR=0.45). In terms of safety as well, the Kisqali combination group had a lower rate of treatment-related serious adverse reactions and treatment discontinuation rate compared to the combination chemotherapy group. Professor Lim said, "The scope of use of CDK4/6 inhibitors including Kisqali in HR+ breast cancer has increased significantly over the past two years. In line with the broadened scope of use of CDK4/6 inhibitors that changed the treatment paradigm of HR+ breast cancer, the ground is being laid to allow their more active use.” Professor Seock-Ah Im-I heard that Asian doctors first suggested the initiation of the RIGHT Choice trial = I am a member of a group of researchers that seek to improve the treatment of young breast cancer patients. As members, specialists from Asian countries, including Korea, Taiwan, Hong Kong, and Singapore, gather together to discuss and study how to improve the treatment environment for young breast cancer patients. During a meeting, the researchers suggested that a combination therapy that uses a CDK4/6 inhibitor could improve the quality of life and have a better antitumor effect than combination chemotherapy, and a research proposal was sent to pharmaceutical companies based on the suggestion. We proposed a study because young patients in their 40s and 50s occupy the majority population in Asia, compared to the West, which is dominated by elderly patients in their 60s and 70s. Breast cancer often takes on an aggressive form among young patients due to the fast cancer growth rate and relatively faster cell division. This means patients are highly likely to have accompanied liver or lung metastases. These doctors had been using chemotherapy as the first-line treatment for HR+ patients because it takes a long time to improve the patient’s symptoms by reducing cancer size with hormone treatment. Chemotherapy allows the tumor size to reduce within 1 to 2 months and the symptoms improve. However, it is also highly toxic. Therefore, a consensus was reached on how combining hormone therapy and targeted therapy instead of chemotherapy, which is difficult to be approved, would yield better results. Novarits’s Kisqalit team accepted the request, and so the RIGHT Choice study was conducted to demonstrate the actual improvement effect.. -How would you interpret the RIGHT Choice trial results? s= There had been clinical trials comparing hormone therapy and CDK4/6 inhibitors with oral anticancer drugs. However, this study is the first to show improvement compared to a combination therapy that is administered in two injections of cytotoxic anticancer drugs. In general, if a patient starts anticancer therapy, the tumor size is first reduced and then starts to grow again. The time until disease progression, that is, the time to symptom relief after chemotherapy and relapse is about 5 to 6 months. In clinical practice, the median time to treatment failure in the Kisqali combination group was 18.6 months, about twice as large as 8.5 months in the control group. Median progression-free survival was also extended by about 1 year compared to the control group. In particular, this study brings more significance because it includes premenopausal women and proves that a more comfortable initial treatment can be performed in premenopausal patients with more aggressive liver cancers or those with lung metastases. The limitation is that the study enrolled patients whose control group could be either one of two cytotoxic anticancer drugs and have a normal range of liver function and daily performance ability to some extent. The study did not include patients whose daily performance is so poor that they are almost bedridden. There are some cases we feel it’s inappropriate to conduct chemotherapy in some patients with visceral metastasis. However, on the other hand, there were many questions about whether it was really okay to use CDK4/6 inhibitor combination therapies. The study convinced me of the potential held by 'CDK4/6 therapy.’ -Kisqality was the last of the three CDK4/6 inhibitors to be introduced to the market. However, if you look at the recent sales records reported by the market research institution IQVIA, Kisqali made notable sales. How reliable are new drugs like Kisqali? =The data was interesting. Having participated in the trial of all three CDK4/6 inhibitors, Ibrance, Verzenio, and Kisqali, I am well aware of the benefits and disadvantages of each drug. Therefore, doctors tend to select drugs after comprehensively considering each patient’s safety, the patient's environment, and condition. In the case of postmenopausal women, side effects such as age, presence or absence of pulmonary embolism or venous thrombosis, and probability of pneumonia are considered. In addition, bone marrow function, liver function, electrocardiogram abnormality, and diarrhea are also considered. However, re-menopausal breast cancer patients didn't have as many options to choose from. Before Ibrance, the patient had to first remove both ovaries to use Ibrance. Fortunately, the combination therapy with Ibrance after ovariectomy did not require chemotherapy, and had only a few side effects other than a slight decrease in white blood cell count, so this method was mainly used. Later, the MONALEESA-7 study played a significant role.in allowing premenopausal women to use Kisqali combination therapy without ovarian resection.
- Company
- One-shot CAR-T tx, approved for domestic items
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- According to related industries, Janssen Korea's Kavicty was approved last month, and Novartis Korea's Kymriah obtained additional approval for indications on the 5th. The second domestically approved CAR-T new drug, Kavicty, is an anticancer drug that inserts genetic information to recognize BCMA into the patient's immune cells (T cells) and then injects these T cells into the patient's body. B-cell maturation antigen, which is selectively expressed during plasma cell differentiation and not expressed in other major organs, represents an ideal target for plasma cell cancer (multiple myeloma). This drug is indicated for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including ▲proteasome inhibitors ▲immunomodulators, and ▲anti-CD38 antibodies. In the case of Kymriah, the indication was expanded to treat adult patients with recurrent or follicular lymphoma after two or more treatments. With this expansion of the indication, Kymriah ▲relapses or secondary relapses after transplantation and subsequent relapses or refractory B-cell ALL (Acute lymphoblastic leukemia) and ▲ in pediatric and young adult patients under the age of 25 A third indication was obtained following recurrent or diffuse large B-cell lymphoma after two or more systemic treatments. Kymriah's new indication was based on ELARA, a phase 2 clinical trial targeting adult patients with relapsed or refractory follicular lymphoma (n=97). As a result of the study, the Overall Response Rate was 86.2%, including 69.1% of Complete Remission. Meanwhile, in March 2021, it was approved as a domestic advanced regenerative medicine bio law No. 1 treatment, and in April 2022, insurance benefits are applied to the two previously approved indications.
- Company
- Roche and Korea BIO offers opportunity to domestic companies
- by Hwang, Jin-joon Apr 11, 2023 06:08am
- KoreaBIO and Roche are hosting an open innovation event(Pic: KoreaBIO) The Korea Biotechnology Industry Organization will be providing opportunities for technology transfer and overseas expansion of domestic biopharmaceutical companies. For this purpose, Korea Bio plans to first cooperate with the multinational pharmaceutical company Roche. According to industry sources on the 10th, Korea BIO is planning to hold a ‘Korea BIO x Roche Partnering’ open innovation event on the 9th of next month. The event will be held on and offline at Roche Korea’s head office in Gangnam, Seoul, and be attended by groups wishing to partner with Roche. The event will offer one-on-one meetings between global pharmaceutical companies and domestic biopharmaceutical companies. Korea BIO planned the event to provide opportunities for domestic pharmaceutical and biohealth companies to receive a diagnosis on their commercialization potential for technology transfer and overseas expansion, etc. Domestic pharmaceutical and biohealth companies wishing to engage in technology transfer and joint research with Roche can submit an application, and prepare nonconfidential company introduction materials, personal information consent form, and company introduction material consent form to Korea Bio by the 24th of this month. The company introduction materials should only include only publicly available data. When the domestic pharmaceutical and biohealth companies submit the required documents, Roche Asia Partnering will select companies after review. Select companies will have on/offline meeting opportunities with Roche, and receive feedback related to the contents discussed. Then, a select few that wish to partner with Roche will receive the opportunity to have face-to-face meetings at Roche headquarters, global branches, and subsidiary research institutes. As collaboration areas, Roche suggested immunology, oncology, neurological disorders, research and development technology, personalized digital healthcare, rare diseases, and infectious diseases. If approved, the collaboration will be carried out with its Genentech Research Center, Roche Innovation Center Basel, Roche’s Shanghai Innovation Center, Global Product Development Department, and Product Strategy Department, etc. The industry believes that Korea BIO's open innovation project will be an opportunity for domestic companies to receive feedback from multinational pharmaceutical companies on their direction of pipeline research, further required research, and the marketability of their candidate substances. Starting with Bayer in 2021, Korea BIO had held open innovation partnering events with Boehringer Ingelheim, Novartis, French Healthcare Club, and CJ in the same year.
- Policy
- 3 combination DM drug is cheaper than the 2 combi
- by Lee, Tak-Sun Apr 10, 2023 05:53am
- 2-drug combination therapy should also be provided with reimbursement standards From this month, as it is applied to the three-drug combination therapy of SGLT2 inhibitors, prescriptions for the existing two-drug therapy (SGLT2i + DPP4i) are expected to decrease significantly. The HIRA said on the 5th through a Q&A related to the reimbursement standards for diabetes medications that will change from this month, “The two-drug combination therapy of a combination of a DPP-4 inhibitor and an SGLT-2 inhibitor is only one type of combination within the scope of approval, as is the case at present. You can apply it with a burden,” he explained. DPP4i+SGLT2i that are currently within the scope of approval are Januvia and Forxiga. The amount the patient will pay is 987 won, which is the sum of 734 won (Forxiga, fully paid by the patient) and 253 won (Januvia, 30% of 846 won). If Metformin is included in the prescription, the drug cost will decrease. This is because from this month, regardless of the ingredients, benefits will be applied to the combined use of met+DPP4i+SGLT2i. This is because if Forxiga 10mg + Januvia 100mg plus Metformin 500mg (highest price 119 won), which is taken daily, the patient's co-payment is only 509 won because 30% is applied. From the patient's point of view, the cost of three drugs has become cheaper than the cost of two drugs. Accordingly, it is analyzed that there is a high possibility that the medical field will prescribe a 3-drug containing metformin instead of an expensive 2-drug. Some experts are concerned that prescriptions for metformin will increase even for patients who do not need to take metformin, and social costs may only increase if prescribed Metformin is not accepted. There is also an opinion of regret that the DPP4i + SGLT2i two-drug regimen is not provided in this reimbursement standard. However, as the reimbursement review for the two-drug combinations is underway, some say that the reimbursement criteria for the two-drug regimen will be established sooner or later.
- Policy
- Reimb review for Pompe disease drug Nexviazyme underway
- by Lee, Tak-Sun Apr 10, 2023 05:53am
- Reimbursement review is underway in Korea for Nexviazyme Inj (avalglucosidase alfa-ngpt), Sanofi’s Pompe disease drug that had been approved by the Ministry of Food and Drug Safety on the 29th. Nexviazyme is the first biobetter among rare disease drugs to be approved in Korea. According to industry sources on the 7th, the Health Insurance Review and Assessment Service started the reimbursement review for Nexviazyme and requested the Ministry of Food and Drug Safety to confirm the drug’s Target Product Profile. Nexviazyme is regarded an upgraded version of the company's Myozyme. The MFDS has been approving products with improved safety, efficacy, and use over existing approved biodrugs or those that were recognized for their progressive technology, as biobetters. Nexviazyme is the first drug among rare disease drugs to obtain marketing authorization as a biobetter drug. Pompe’s disease is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA). When left untreated, it may lead to muscle damage, respiratory failure, movement disorders, and even premature death. The company has implemented innovative technology to increase the amount of mannose-6-phosphate (M6P), which plays a major role in the drug's cellular enzyme uptake, in Nexviazyme by 15 times compared with Myozyme. The company added, the increase in M6P also improves immunogenicity and provides safety benefits. Myozyme is currently reimbursed at KRW 653,000 per vial. In 2021, USD 7.7 million's worth of Myozyme was imported to Korea.
- Company
- Two types of RET-targeted anti-cancer drugs for minority pts
- by Eo, Yun-Ho Apr 10, 2023 05:52am
- It does not seem easy to enter the insurance coverage of RET-targeted anti-cancer drugs targeting a very small number of patients. According to related industries, Retevmo of Lilly Korea failed to pass the HIRA held on the 6th, and Roche Korea's Gavreto submitted an application for benefits last year, but it has not yet been presented to the Cancer Disease Review Committee, and discussions are slow. However, in the case of Retevmo, as the decision to re-discuss was made, there is room for hope. Although the application for Gavreto was delayed compared to Retevmo, there is no news about it, despite the strong tendency of the government to evaluate drugs with the same mechanism. Retevmo and Gavreto both obtained FDA approval in March. Retevmo was a bit early for global first permission. Retevmo obtained marketing approval from the US FDA in May last year and Gavreto in September last year. Retevmo was approved for two indications of non-small cell lung cancer and thyroid cancer, and for indications of Gavreto, thyroid cancer was added in December of the same year after approval as a lung cancer treatment. Since these drugs suppress not only the primary mutation of the RET gene but also the secondary mutation that causes resistance to chemotherapy, it was expected that they would be able to solve the unmet demand in various types of cancer, but they are experiencing difficulties in the insurance coverage process. Cho Byung-cheol, a professor at the Lung Cancer Center at Yonsei Cancer Center, said, "Until now, there were no chemotherapy options for patients with RET gene mutation cancer, so we had no choice but to undergo chemotherapy in the same way as general cancer patients. It can be an alternative for patients who have had difficulties with relatively low anti-cancer toxicity.” Meanwhile, in the LIBRETTO-001 clinical trial, Retevmo recorded a response rate of 64% in non-small cell lung cancer patients who had previously received platinum chemotherapy and an 85% response rate in the newly diagnosed group. Gavreto significantly reduced tumors by 58.8% in non-small cell lung cancer patients who had previously received chemotherapy in the Arrow trial. In patients diagnosed for the first time, the response rate was 72%.
- Policy
- Only a few cold drugs will be subject to PVA negotiations
- by Lee, Tak-Sun Apr 10, 2023 05:52am
- The number of drugs subject to negotiations under the Price-Volume Agreement (PVA) system among cold medicines and antibiotics whose usage increased explosively with the rise in the number of confirmed COVID-19 patients, is expected to be small. When the National Health Insurance Service applied the correction plan it had devised after collecting industry opinion, results showed that little more than 10 items were subject to negotiations. Such results will be applied around the end of April when the government monitors PVA ‘Type C’ drugs. According to industry sources on the 8th, the NHIS corrected the use amount of about 2,600 cold medicines and antibiotics whose use had increased due to COVID-19 and simulated the number of items that will be subject to negotiations. Results showed that the subject drugs were reduced to around 10. The correction was made by comparing each drug’s use amount with the previous year after excluding their usage from a specific month when the number of COVID-19 cases increased explosively. When applying the correction, most of the drugs were not subject to receive negotiations. In other words, their amount of use was similar to the previous year, if not for the COVID-19 crisis. Drugs fall under Type C when claims of products in the same therapeutic class increase by over 60% from the claims amount filed in the previous year, or have increased by over 10% but the increased amount exceeds KRW 5 billion. Items that did not undergo NHIS negotiations on their expected claims amount fall under ‘Type C.' Most of the cold medicines and antibiotics that the correction plan will be applied to fall under PVA ‘Type C.' Therefore, the NHIS plans to apply the final correction plan when monitoring drugs for Type C PVA negotiations. As monitoring is expected to begin at the end of April, the industry expects the correction plan to soon be finalized.
- Company
- It is difficult to secure domestic funding for bio ventures
- by Hwang, Jin-joon Apr 10, 2023 05:51am
- Head of KDDF, Muk Hyun-sang, is presenting major business plans for this year. (Photo: Dailypharm)"It is not easy to change KDDF's funding method. It is possible to raise funds only when investors flock to it, but in order to attract funds from the United States, we are planning an event to invite major US VCs to invest in Korean bio ventures in July. are doing." Muk Hyun-sang, head of KDDF, made this announcement at a press conference held on the 5th at the Korea Chamber of Commerce and Industry's mid-sized conference room in Jung-gu, Seoul to mark the 2nd anniversary of KDDF's launch. Director Muk Hyun-sang explained, "I thought KDDF funds were priming water," and explained, "If you support about 10% of the necessary R&D costs, the company has raised 15 billion won by itself, but it is currently difficult." "It is difficult to increase the amount of money that can be supported by KDDF," he said. "We are looking for a way to get funds from the outside. The US VC invitation event plan is one of the ways to connect financing." KDDF plans to invest a total project cost of 2.1758 trillion won by 2030. The business goals are 60 global technology transfers worth 20 billion won or more, 35 cases worth 100 billion won or more, 4 new drug approvals from the FDA and the EMA, and the creation of one global blockbuster new drug with annual sales of 1 trillion won or more. Director Muk said, “The business carried out by KDDF cannot be seen as a general state-sponsored new drug development project.” there is, and if a company is short of funds, KDDF should create an opportunity to raise funds." KDDF is also planning to carry out 'ADCaptain' to support the ADC project, which is considered a next-generation treatment this year. KDDF plans to prioritize pipelines targeting pancreatic cancer, ovarian cancer, and triple-negative breast cancer among solid cancers and strengthen support through the ADCaptain project. It plans to provide R&D subsidy through investment without equity dilution and support up to 20 million dollars by 2025. From this year to next year, it plans to establish a joint operating committee through cooperation between participating companies and investment companies in the form of a virtual company. A science development advisory committee will also be operated. KDDF plans to select three tasks as leading material development tasks and support 800 million won each for two years. When it enters the development stage after 2024, it plans to establish a corporation and distribute shares. The CEO will be nominated by the company in charge of clinical development. The chairman of the board of directors is appointed by KDDF. R&D funds will be raised through KDDF R&D subsidy, global VC investment, and government fund investment. The required investment is expected to be 24 million dollars. Director Muk said, "It has become KDDF's mission to raise funds. We submitted a budget plan related to new drug development worth 250 billion won to the Abu Dhabi Investment Authority through the Ministry of Strategy and Finance, and we will contact Singapore's Temasek."
- Company
- GemVax’s Alzheimer’s Tx GV1001 receives IND approval
- by Kim, Jung-Ju Apr 07, 2023 05:55am
- On the 4th, GemVax & KAEL announced that it had received investigational new drug (IND) approval for the Phase II trial of its Alzheimer’s treatment candidate, GV1001, in 7 European countries as planned. With its procedures for clinical trial approvals in the 7 European countries complete, the company plans to accelerate the clinical trials in Europe, starting with the initiation of the clinical trial in Spain. A GemVax official said, “With approval complete in 7 European countries, we expect the clinical trials we initiated in Europe to speed up. The global clinical trial of our Alzheimer's disease treatment GV1001 is progressing smoothly in the U.S. and Europe, therefore, we will do our best to achieve significant clinical results." The company plans to enroll a total of 185 patients, 77 from the US and 108 from Europe in the global clinical trial for GV1001. The company explained that the first patient was registered in the US last October and that a total of six patients have been registered so far. The clinical trial will evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) subcutaneously as a treatment for mild-to-moderate Alzheimer's disease (AD) for 53 weeks (12 months). In addition, GemVax has also received approval from Korea’s Ministry of Food and Drug Safety to conduct a clinical trial on GV1001 as a treatment for progressive supranuclear palsy (PSP). This is expected to become the first clinical trial conducted in Korea for PSP. As GV1001 is being studied for PSP in addition to the Alzheimer's disease clinical trials that are being actively conducted in Korea and abroad, GV1001’s scope is expected to expand further to cover a range of neurodegenerative diseases.
- Company
- The dilemma of price cuts for Lipiodol and Fattiodol
- by Nho, Byung Chul Apr 07, 2023 05:55am
- There are many opinions of concern that the two items of X-ray contrast medium registered as essential medicines may fall into a situation where supply is not possible. According to the industry, price cuts are scheduled for Lipiodol and Fattiodol on the 1st of next month, and the price of raw materials for these products is high. The original product, Guerbet Fattiodol Ultra, obtained domestic approval in 1998 and was recognized for its insurance price of 52,560 won in 2016. Afterward, the pharmaceutical company filed an application for drug price adjustment with the health authorities in 2018, citing lower margins compared to cost, and was found to have led to a drug price increase of 190,000 won, a 261% increase from the previous one. Lipiodol is 189,224 won in January 2022, 133,000 won in September 2022, 189,224 won in September 2022, and 133,000 won in January 2023. The drug price is scheduled to be reduced to 1,745 won. The situation is equally bad for Dongkuk Fattiodol, the only generic drug in the market approved in 2020. At the time of registration, the additional drug price was recognized and 59.5% (113,050 won) of 190,000 won was recognized, but the drug price is scheduled to be reduced to 101,745 won on the 1st of next month. Application for drug price adjustment is virtually the only way to raise or preserve drug prices, but it cannot be used because there are alternative drugs between Lipiodol and Fattiodol. If two pharmaceutical companies simultaneously stop supplying drugs due to lower margins following drug price cuts, a supply-demand crisis is expected. An industry insider said, "Estimating the cost of essential medicines and resolving the dynamics of drug price cuts is a mid-to-long-term task that the health authorities must solve." The main component of Lipiodol is Ethyl Esters Of The Iodised Fatty Acids Of Poppyseed Oil, which is used for lymphography, salivary gland imaging, carotid artery chemoembolization for liver cancer, and hysterosalpingography. Last year, Lipiodol and Fattiodol last year's performance were about 2.8 billion won and 36 million won, respectively.
