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- 2026-05-15 21:38:33
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- Aftermath of Revlimid of primary benefit multiple myeloma
- by Whang, byung-woo Apr 28, 2022 06:06am
- As Revlimid (Lenalidomide Hemihydrate) based chemotherapy enters the benefit, changes in RRMM prescription patterns are inevitable. Kyprolis-centered KRd therapy (Carfilzomib+Revlimid+Dexamethasone) and Ninlaro-centered IRd therapy ( As both Ixazomib+Revlimid+Dexamethasone) contain Revlimid, there are concerns at the clinical site about how to take follow-up prescriptions. Revlimid's benefit has been reimbursed for RVd therapy (Lenalidomide + Bortezomib + Dexamethasone) and R2 therapy (Lenalidomide + Lituximab) since April. RVd therapy was recommended as the primary treatment for multiple myeloma in the NCCN and ESMO guidelines, but benefits were not applied until April in Korea. For this reason, clinical sites have expressed opinions on the need for benefits of RVd therapy and R2 therapy. As RVd therapy becomes available for primary treatment, discussions on the use of KRd therapy and IRd therapy, which were prescribed in RRMM, continue In the case of multiple myeloma, there is a possibility of continuous recurrence, so it is prescribed by taking a different combination of treatments that can be used for each order. It was impossible to prescribe IRd therapy if KRd therapy was used in the past, so a treatment strategy was used to use KD therapy in the next order of treatment after using IRd therapy at the discretion of the medical staff. Experts believe that as RVd therapy is used for primary treatment, the use of KRd therapy and IRd therapy containing Revlimid will also be reduced. Professor Kim Seok-jin of the Department of Hematology and Oncology at Samsung Medical Center said, "If RVd is used as the primary treatment, KRd and IRd will inevitably be affected." "This benefit is meaningful," he explained. It is not that IRd therapy cannot be used when RVd therapy is used in primary treatment and KRd therapy on which Rd therapy is based. After diagnosis, multiple myeloma is divided into a "transplant target group" and a "non-transplant target group" depending on whether hematopoietic stem cell transplantation is possible, and Takeda explains that patients can be treated with the same benefit as now after recurrence even if VRD is applied as the primary treatment. The prerequisite is that VRd therapy is transplanted after 6 cycles and recurrence after maintaining the reaction for more than 6 months. In the case of non-transplantation groups, the use of VRD as Until Progression as primary treatment makes it difficult to apply both R-based treatments, including IRd and KRd, which are currently available for benefit prescriptions, in the second. #Will it be established as KRd/IRd therapy maintenance therapy in non-transplant patients? Then, how many patients can use KRd and IRd therapy according to the entry of RVd therapy into primary treatment? Lee Je-joong, a professor of hematology at Hwasun Chonnam National University Hospital, said, "In the group of patients who can be transplanted, RVd is performed for about four cycles and most of them react, so most of the patients can use both KRd and IRd as secondary therapy. In terms of the total number of patients with multiple myeloma, 55% of them can be transplanted, and 90% of them will be able to use KRd and IRd therapy." There is no significant difference from the previous one in patients who can be transplanted, but experts predict that it will be Kd therapy for Cypriot and maintenance therapy for ninjas as it is difficult to use KRd and IRd in secondary treatment for non-transplant patients. Both options are continuously confirmed through current research to expand indications and confirm their efficacy. Kd therapy has the result of extending the survival period compared to Vd therapy by another 12 months in RRMM patients who previously received one treatment, including elderly patients, who are the main patients with multiple myeloma. Since May last year, Kyprolis has obtained additional indications for the dose of Kd once a week in the treatment of RRMM patients, and the fact that both Kd once a week and twice a week are covered by insurance benefits is also expected to have a positive effect. In addition to IRd therapy, Ninlaro has indications for maintenance therapy for patients who received autologous hematopoietic stem cell transplants and those who did not receive them in March and September last year, respectively. However, in the case of maintenance therapy, it was not reimbursed.
- Company
- Novartis' anticancer drug/Rx division will be merged
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- A change is expected in Novartis' subsidiary. Above all, the anticancer drug division and the Rx division, which have been operated independently, will be integrated. According to related industries, Novartis' Asia-Pacific Regional Headquarters has already been appointed as a representative of the integrated corporation. As a result, corporations such as Novartis Korea will also integrate their business units within this year. The anticancer drug division is led by CEO Shin Soo-hee, and the Rx division is led by CEO Yoo Byung-jae, who was appointed last year. The company consists of two business units, not only marketing and sales, but also support departments such as drug prices, rental, and permission. Therefore, if the integrated general manager is determined, manpower adjustment will be inevitable. Novartis' headquarters announced in April that it would introduce a new organizational structure and operating model designed to support innovation, growth and productivity goals as a pharmaceutical company looking forward to a new decade. As part of the reorganization, Novartis plans to merge its pharmaceutical and anti-cancer operations and create two independent commercial organizations, the U.S. Department of Innovative Medicine and the International Department of Innovative Medicine. Both organizations will have full profit and loss liability and customer experience, marketing, sales, sales ownership, and market access to each market across all treatment areas.
- Opinion
- [Reporter’s View]Recall the purpose of regulating biologics
- by Apr 27, 2022 06:04am
- The Ministry of Food and Drug Safety visited 3 pharmaceutical distributors on the 21st to prepare a new guideline that reflects voices in the field and the realistic difficulties of the industry in preparing to comply with regulations on the distribution of biological products. The government is resetting the guideline after the revised version of the ‘regulation on the Manufacture and Sales Management of Biological Products’ was implemented in January last year faced with strong opposition from the pharmaceutical distribution industry on the sudden rise in the distribution standards of biological products without considering the cost or preparation period. The raised standards increased the cost of transporting biologicals that already have low distribution fees to the extent that many companies decided rather not to distribute them. Also, the industry pointed out the difficulties in managing the temperature of biological products that have to be frequently shipped in small amounts to pharmacies like insulin. Under the revised regulations, it is necessary to maintain 2-8 degrees at all times using transport containers equipped with automatic temperature recording devices when delivering biological products, and the record must be kept for two years. Unlike the regulations that forbid even a single deviation from the designated temperature, there are times when the temperature may suddenly jump out of the reference range for unknown reasons in reality. Although this has no effect on the efficacy of the drug because the temperature does not deviate for a long period of time, they are subject to punishment under the regulations. This is why the distributors are struggling with the issue. A representative of a company has been testing various transportation containers every day, including custom-made containers, but has not been able to find a solution even now. It also depends on which and how many refrigerants are added. This is why the industry is making complaints and requesting that the MFDS should suggest the type and number of refrigerants and containers used that are not too heavy, not too expensive, and have good temperature control for 24 hours. This is the result of overlooking the fact that it takes a lot of money and a long preparation period to prepare a perfect cold chain. More than 90% of pharmaceutical distributors are small and medium-sized enterprises (SMEs) that cannot afford to spend a lot of money on the cold chain of biologics. However, the government implemented the revised regulations in just 6 months since it was announced, in a hurry to implement the regulations within the year. Faced with backlash from the industry, the authorities granted a 6-month guidance period, but the end of the guidance period is now less than three months away. The MFDS said it will include the details in the guidelines, but the problem is time. If the companies do not abide by the regulations, they will be subject to punishments starting on July 17th. There is not enough time for the authorities to rewrite and announce the guidelines and for the companies to complete preparations accordingly. The original purpose of strengthening the regulations for the transport of biological products was to enable the safe delivery of drugs that are directly related to the people's right to health. However, such hasty measures that are focused on administrative procedures and written deadlines leave much room for issues in the regulations that were made with good intentions. This is why the government should show patience and take the right steps step by step so as not to defeat the purpose of strengthening the regulations.
- Company
- Additional formulations of Abbvie’s Skyrizi were approved
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- The approval of an additional formulation of the IL-23 inhibitor ' Skyrizi' has increased the drug’s versatility in the field of plaque psoriasis. On the 22nd, Abbvie Korea announced that the Ministry of Food and Drug Safety additionally approved its Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg formulations of its IL-23 inhibitor ' Skyrizi Prefilled Syringe Injection (risankizumab)’ for the treatment of adult patients with moderate-to-severe plaque psoriasis. With the approval, Skyrizi may additionally be administered 4 times a year as maintenance therapy in two formulations - Skyrizi Prefilled Syringe 150mg and Prefilled Pen 150mg. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading the development and global sales of the drug. The 150mg formulation of Skyrizi is administered through a single shot of a 150mg injection. It is administered twice as a subcutaneous injection early on (at week 0, week 4), then every 12 weeks thereafter. The previously approved 75mg formulation was administered in two shots per visit. The approval of the new 150mg formulation would allow for the number of annual shots required by half. In other words, the newly approved dose of Skyrizi is 150mg (2 shots of 75mg prefilled syringe or 1 shot of Skyrizi Prefilled Syringe 150mg or Prefilled Pen 150mg) administered subcutaneously at week o and week 4, and every 12 weeks thereafter. Eun-Joo Park, Professor of Dermatology at Hallym University Sacred Heart Hospital said, “Skyrizi as a maintenance treatment demonstrated a consistent safety profile and a high skin improvement effect that can be maintained in the long-term with 4 doses a year in various clinical trials. The addition of the 150mg dose that allows for patients to receive the required dose with a single shot, would increase convenience among HCPs and patients as well as broaden their range of choices.” Skyrizi can be subcutaneously administered at hospitals or be administered at home after receiving training for subcutaneous injections. The new 150mg Prefilled Pen that was additionally approved was devised to improve the treatment experience for the patients. Abbvie explained that the additional approval of the new formulation was based on clinical results that demonstrated that a single shot of the Skyrizi Prefilled Syringe 150mg met the primary efficacy endpoint was bioequivalent to two shots of the existing 75mg formulation. The Prefilled Pen 150mg formulation also demonstrated its bioequivalence with the Prefilled Syringe 150mg. Skyrizi is an IL-23 inhibitor that selectively inhibits IL-23 by binding to its p19 subunit. IL-23 is involved in various chronic immune-mediated conditions including psoriasis. The 150mg formulation was approved by the European Commission in May 2021 to treat moderate to severe plaque psoriasis in adults after systemic or phototherapy. Phase III trials on Skyrizi in psoriasis, Crohn's disease, ulcerative colitis, and psoriatic arthritis are still ongoing. In Korea, the drug was approved in December 2019 as a treatment for adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy (including biological therapy). The drug then added the psoriatic arthritis indication on the 5th of last month. Skyrizi may be used to treat adult patients with active psoriatic arthritis who responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
- Policy
- The transition team operates biohealth regulatory sandboxes
- by Kang, Shin-Kook Apr 27, 2022 06:03am
- The presidential transition committee established the Pharmaceutical Bio Innovation Committee, which was the pledge of Yoon Seok-yeol, and presented deregulation through biohealth regulatory sandboxes as a policy task. Baek Kyung-ran, a member of the transition team's social welfare division, said on the 25th that he will recognize the biohealth sector as a future food industry and open the 'BioHealth Korea Era' through a briefing on vaccine development and state affairs. Member Baek said, "This morning, elected Yoon visited the headquarters of SK Bioscience, which is developing the COVID-19 vaccine," adding, "The purpose of the on-site visit is to encourage everyone who has participated in the development of the COVID-19 vaccine. It was to express our willingness to actively support the bio-health sector." "Yoon said that there is enormous national potential, food, economy, and health security in the vaccine treatment lab," Baek said. "In the future, the government will provide all support to companies that develop vaccines and treatments to respond to pandemics." He said, "The Yoon Seok-yeol government recognizes the bio-health sector as an axis of the future food industry and establishes national tasks with the aim of opening the 'Bio-Health Korea Era' by making it a field that takes a step ahead and leads other countries." "First of all, we will create an environment where our bio-health companies can leap into the world, we will establish a pharmaceutical bio innovation committee to strengthen biohealth governance so that basic research, hospitals and companies can cooperate together and related ministries can gather wisdom together." In addition, he said, "We will create a global mega fund that supports our pharmaceutical industry to develop innovative new drugs by our own strength beyond the limitations of technology exports." "We plan to actively train key personnel such as medical scientists and AI professionals and operate biohealth-specific regulatory sandboxes to improve regulations in the biohealth sector at all times," Baek said. It also unveiled measures to foster the digital healthcare industry. "To strengthen the industrial competitiveness of digital healthcare products such as electronic drugs, digital treatment devices, and AI diagnostic assistance, we will strengthen R&D," she said. "We will build a medical MyData platform that allows medical institutions, pharmacies, and insurance companies to flow." "We will also strengthen the legal basis so that new technologies and data platforms can be safely used without concerns over personal information infringement," Baek said. "We will establish a system that enables discriminatory support for areas directly related to health and security like infectious diseases. The U.S. invested about $10 billion immediately after the outbreak of COVID-19 to make its first vaccine in 350 days." Even after COVID-19, a new type of new infectious disease can occur again at any time. We also need a system that supports in a different and innovative way than ever before," she said. "We will fundamentally reorganize the R&D system by establishing a dedicated organization to minimize administrative regulations such as preliminary feasibility systems and provide rapid support," Baek said. "Biohealth is not only a promising field of our economy, but also a key area to improve the health and quality of life of the people. We will try to lead the growth and job creation of our economy by converging industry, science and technology, and medical care around the people and becoming a "second semiconductor," he stressed.
- Policy
- Betamethasone's permission change is expected
- by Lee, Hye-Kyung Apr 27, 2022 06:03am
- As a result of reviewing safety information on drugs containing the skin disease treatment Betamethasone, precautions for use such as Pheochromocytoma are expected to be added. The MFDS' Pharmaceutical Safety Evaluation Division prepared a change (draft) of permission based on the results of the European Medicines Agency's review of safety information on drugs containing "Betamethasone." This change includes both Betamethasone PO and Betamethasone Inj. "Pheochromocytoma, which could be fatal, were reported after administration of systemic corticosteroids. Patients suspected or confirmed to have Pheochromocytoma should be administered only after evaluating the appropriate risk and benefit of Corticosteroids.' For injections, general precautions include oral medications, while the terms of administration for pregnant women and lactating women added, "The study showed an increase in the risk of neonatal hypoglycemia after short-term treatment of Betamethasone before childbirth." The MFDS will receive an opinion inquiry by the 6th of next month regarding the establishment of such precautions. Betamethasone-containing PO products include Sinil Betamethasone, Ceretasone, Dexmin, Dongkoo Bio's Betamethason, Betaramin (for export), Cebita, Cerestar (for export), Almetamine (for export), Didstarsone, Benoramin, Arlico Betathro, Betomin, Young IL BETALOMIN, Gestar, and Betaclon. Betamethason-containing Inj. products include Betamethone Sodium Phosphate Injection Medica, Betamethasone Injection Jeil, Globetamethasone Injection, Betamethasone Sodium Injection Huons, Betamethasone, Tamezon, Betamethasone Sodium Injection Tab. Daewon, Betasone Injection Dongkwang and Hanall Betamethasone Inj.
- Company
- Benefit of Pfizer's Cibinqo is applied
- by Eo, Yun-Ho Apr 26, 2022 06:12am
- Another JAK inhibitor aims to enter the atopic dermatitis insurance benefit right. According to related industries, Pfizer Korea recently submitted an application for benefits of Cibinqo, a new drug for JAK1. As Lilly's Olumiant and AbbVie's Rinvoq are expected to be applied in May. Cibinqo was approved in Korea in November last year when the listing process of Olumiant and Rinvoq was underway. There was an observation that Cibinqo would also hurry to apply for registration and proceed with the registration process together, but the timing of Pfizer's application was later than expected. This drug acts as a mechanism to control the levels of IL 4, 13, 31, and 22 and TSLP on the thymus substrate, which are involved in the pathophysiological characteristics of atopic dermatitis. The permitted indication is the treatment of symptomatic atopic dermatitis in moderate cases of adults and adolescents aged 12 or older. Cibinqo proved its effectiveness through phase 3 clinical studies such as JADEMONO-1, MONO-2, and COMPARE. In the 12th week, the eczema severity evaluation index was lowered by more than 70%, and the treatment effect was proved in indicators such as relieving itching within two weeks of treatment. Among them, the JADE Mono-1 study randomly assigned and analyzed oral Cibinqo 100 mg, Cibinqo 200 mg, or placebo administration groups once a day for 12 weeks for patients with severe-moderate atopic dermatitis over the age of 12. In the Cibinqo 200m group, 63% of patients achieved a 75% improvement in Eczema Severity Index (EASI) at 12 weeks of treatment, compared to 12% in the placebo group, and 90% improvement in Eczema Severity Index (EASI-90) at 39%.
- Company
- RET targeted therapy Retevmo opens era of precision medicine
- by Apr 26, 2022 06:12am
- Lilly Korea’s RET targeted therapy Retevmo(selpercatinib) has landed in Korea. The drug is expected to become a new treatment option in RET fusion-positive patients with non-small-cell lung cancer and thyroid cancer. Lilly Korea held an online press conference to celebrate the approval of Retevmo on the 25th. Professor Min Hee Hong of Oncology at Yonsei Cancer Center and Professor Won Gu Kim of Endocrinology and Metabolism at Asan Medical Center attended the virtual event to explain the significance of Retevmo’s approval. Retevmo was approved by the Ministry of Food and Drug Safety in March last year as a treatment for RET fusion-positive NSCLC and thyroid cancer patients. More specifically, the drug 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. At the press conference, Professor Hong said, “Lung cancer patients with RET mutations are twice more likely to experience CNS metastasis, but had to be treated with chemotherapy, which is less effective and more prone to toxicity due to the lack of RET targeted therapies. Retevmo demonstrated significant response in the LIBRETTO-001 trial, as well as an 82% ORR in patients with CNS metastasis. 23% of these patients achieved complete response.” Kim added, “Although the survival rate for thyroid cancer is known to be high patients with RET point mutated medullary thyroid cancer have a poor prognosis and low survival rate. Also, patients with thyroid cancer who are refractory to radioactive iodine therapy have a low survival rate and life expectancy. Retevmo has shown a 79% and 69% ORR in the abovementioned patient groups, opening a new era of precision medicine.” RET mutations occur in 2 to 6 % of all NSCLC cases and are more often found in adenocarcinomas and younger patients under 60 years of age and non-smokers. In NSCLC, RET fusions occur more than RET mutations. In thyroid cancer, RET fusions are reported in up to 40% of the cases. RET fusions can be identified through rest such as NGS, FISH, RT-PCR, etc. Among the tests, NGS is known to be the most effective diagnostic method for identifying RET fusions. However, it takes around one month to receive results after NGS testing, and as ‘Keytruda,’ a reimbursed immunotherapy option already exists for NSCLC in the first line, it is highly likely that Retevmo will not be selected as a first-line treatment in these patients. Professor Hong said, “As RET fusion is not a common mutation, we cannot idly just wait for the test results, therefore it is likely that we will use immunotherapies first. However, using immunotherapies before Retevmo may reduce the response rate to Retevmo, this is why it is important for us to receive the NGS results as quickly as possible.”
- Company
- President-elect Yoon visits SK Bioscience HQ
- by Kim, Jin-Gu Apr 26, 2022 06:12am
- President-elect Suk-yeol Yoon visited SK Bioscience headquarters in Seongnam, Gyeonggi-do, and promised “We will spare no effort in the development of vaccines so no one can say they could not develop vaccines due to lack of money.” Transition team chair Cheol-soo Ahn and members of the Social Welfare subcommittee of the transition team accompanied Yoon to the site, and Tae-won Chey, Chairman of SK Group, and Jae-Yong Ahn, CEO of SK Bioscience were also present at the site. According to SK Bioscience, president-elect Yoon observed the entire vaccine R&D process, from the extraction of animal cells used for vaccine development and production to culturing, fermentation, purification, and analysis. Yoon said, “I will visit more R&D sites in the future. Korea’s economy, security, and health all depend on this.” Yoon said, “In my administration, I plan to spare no support for companies that develop vaccines and treatments for the pandemic, including SK Bioscience. If companies ask for loosening of some regulations in the R&D process, I will actively review it and make sure that the companies are not inconvenienced." Jae-Yong Ahn, CEO of SK Bioscience, said, “We need steady support from the government to continue on our hard-earned vaccine development capabilities." Transition team chair Cheol-soo Ahn said, “The new virus is an important national crisis that requires continued management. Using this as an opportunity, it is the new administration’s task to create a data-driven disease control and prevention system. To SK Bioscience, transition team chair Cheol-soo Ahn said,” The NA had always deferred making decisions on vaccine-related budgets as a low priority agenda, but the new administration’s goal is to secure vaccine sovereignty in Korea by investing in vaccine development so Korea could gain vaccine development capabilities.” On the morning of the same day, SK Bioscience had announced that its own synthetic antigen COVID-19 vaccine candidate’GBP510’ had shown superior immune response to its comparator in a Phase III clinical trial. After securing safety data on GBP510 within the month, the company plans to apply for domestic and overseas approvals for its drug as a vaccine used for COVID-19 prevention after basic vaccination .
- Company
- Cancer immunotherapy are being applied to expand benefits
- by Eo, Yun-Ho Apr 26, 2022 06:11am
- Tecentriq will apply primary therapy benefits for liver and non-small cell lung cancer from May According to related industries, Roche Tecentriq will be applied to liver cancer and non-small cell lung cancer indicators from May as Merck and Pfizer Bavencio (Avelumab) passed the Cancer Drugs Benefit Appraisal Committee. The benefit standards were set as the first solo maintenance therapy in adult patients with local progressive or metastatic urinary tract epithelial cell cancer that did not progress in platinum-based chemotherapy treatment. If benefit adequacy is recognized by the HIRA's Drug Benefit Evaluation Committee and drug price negotiations are concluded with the NHIS, it will be eligible for insurance benefits. In the case of Tecentriq, benefits will be applied in the first monotherapy if it is a metastatic non-small cell lung cancer with positive PD-L1 expression and no EGFR or ALK mutation from the 1st of next month. It succeeded in applying liver cancer benefits for the first time among immuno-cancer drugs. Combination therapy of Tecentriq and Avastin (Bevacizumab) can be given first-line benefit if both 3 or higher, Child-Pugh class A grade, and ECOG PS) 0 to 1 point are satisfied among patients with advanced hepatocellular carcinoma that cannot be operated or treated locally. MSD's Keytruda has expanded its standards for primary therapy for non-small cell lung cancer since last month. Benefits are also applied to patients with recurrent or refractory Hodgkin lymphoma and children aged 2 or older who have failed at least two previous treatments, patients with progressive (stage 4) non-small cell lung cancer with positive PD-L1 expression and no EGFR or ALK mutation, patients with metastatic non-flat non-small cell lung cancer without EGFR or ALK mutation, patients with metastatic squamous non-small cell lung cancer, and if autologous hematopoietic stem cell transplantation fails, or autologous stem cell transplantation is not a treatment option. Benefits are also applied to patients with recurrent or refractory Hodgkin lymphoma and children aged 2 or older who have failed at least two previous treatments, patients with progressive (stage 4) non-small cell lung cancer with positive PD-L1 expression and no EGFR or ALK mutation, patients with metastatic non-flat non-small cell lung cancer without EGFR or ALK mutation (combined with chemotherapy), patients with metastatic squamous non-small cell lung cancer (combined with anticancer chemotherapy), and if autologous hematopoietic stem cell transplantation fails, or autologous stem cell transplantation is not a treatment option.
