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- 2026-04-12 18:23:58
- Policy
- BMS acute myeloid leukemia tx Onureg was approved
- by Lee, Hye-Kyung Mar 29, 2022 05:54am
- Onureg 200mg and Onureg 300mg, the first PO drugs were approved. Currently, Azacitidine-based AML treatments, which are approved in Korea, are injections with Celgene's Vidaza100mg, Boryung Pharmaceutical's Vizadakin and Samyang Holdings' Azalid 100mg and Azalid 150mg, and Onureg has become the first oral treatment. The MFDS (Director Kim Kang-rip) recently approved BMS' AML treatment Onureg (Azacitidine). Onureg is an oral drug with a pink oval film coating and has the advantage of being administered regardless of meals. Indications can be used to achieve CR or CRi with incomplete hematological recovery after induction therapy, regardless of whether or not publicly announced therapy is performed, and to maintain therapy in adult patients with acute myeloid leukemia who are not suitable for HSCT. To administer Onureg, it must be initiated and monitored by a physician who has experience in chemotherapy, and should not be used interchangeably with injectable Azacitidine due to different exposure, dose, and administration schedules. Meanwhile, Onureg has been in the process of licensing items in Korea since the U.S. FDA approved in 2020.
- Company
- Wakix, a narcolepsy tx, can be prescribed at hospitals
- by Eo, Yun-Ho Mar 29, 2022 05:53am
- Wakix, a narcolepsy treatment, can be prescribed at general hospitals. According to related industries, Mitsubishi Tanabe Pharma's Wakix passed the Drug Committee of Seoul National University Hospital and other medical institutions. Wakix has been competing with Handok Teva's Nuvigil since last month as insurance benefits have been available. This drug is a new mechanism for increasing histamine concentration in the brain as a counteractive and antagonist that selectively binds to histamine H3 receptors. Nuvigil, an active isomer of sleep seizure treatment Provigil, is a drug that promotes awakening by activating dopamine in the brain and improves the duration of existing drugs. Hypnosis, a rare and intractable disease, has limited treatment options in Korea. In the United States and Europe, Modafinil, Sodium oxybate, Solriamfetol, and Pitolisant are used as narcolepsy treatments, but only Modafinil and isomeric Armodafinil are licensed in Korea. Narcolepsy is a sleep disorder disease characterized by confusion in the sleep awakening cycle and abnormal expression of REM sleep due to the loss of neurons that produce a neurotransmitter called Hypocretin in the brain. Symptoms include EDS (Excessive Daytime Sleepiness) and cataplexy, where REM sleep is expressed in awakening. Cataplexy is known to occur in 70% of narcolepsy patients. Wakix is the first drug approved in Korea to prove its clinical efficacy and safety. Wakix, a new drug developed by French pharmaceutical company Bioprojet Pharma, has been prescribed to narcolepsy patients in European countries such as the UK, France, and Germany since it was first approved as a rare drug by the EMA in March 2016. In August 2019, it was approved by the FDA.
- Company
- Expanding Entresto benefits/maximizing tx for inpatients
- by Mar 29, 2022 05:53am
- Entresto, Novartis' chronic heart failure treatment, has expanded both indications and benefits. Enresto can be used even in patients with more than 40% and less than 60% of the ejection fraction, which has been in great demand. In addition, it is expected that Entresto's position will be further strengthened as hospitalized heart failure patients can use Entresto as a primary drug. Novartis Korea held an online press conference on the 24th to commemorate the expansion of Entresto benefits and indications. Kang Seok-min, a professor of cardiology at Yonsei University's Sinchon Severance Hospital, and Cho Hyun-jae, a professor of circulatory medicine at Seoul National University Hospital, attended to share the meaning of expanding benefits. rom the left, Park Soo-jin, director of the Cardiovascular Metabolism Division of Novartis Korea, Kang Seok-min, professor of cardiology at Yonsei University Sinchon Severance Hospital, and Cho Hyun-jae, professor of circulatory medicine at Seoul National University Hospital Entresto is the first Angiotensin receptor-Neprilsysin inhibitor (ARNI) treatment in Korea and the only new drug that works directly on the heart. It acts on cardiac nerve hormones in two ways to activate NP nerve hormones that are beneficial to cardiovascular systems, while suppressing RAAS that is harmful to cardiovascular systems. In February, Entresto added an indication of 'reducing the risk of death from cardiovascular disease and hospitalization due to heart failure' in patients with chronic heart failure with lower left ventricular systolic function than normal. Starting this month, for patients who have been hemodynamically stabilized after hospitalization due to acute non-compensatory heart failure, salaries have also been expanded to those without ACE inhibitors or angiotensin II receptor blocking. Entresto can be reimbursed as a primary drug for inpatients. According to Professor Kang Seok-min, 83% of patients with chronic heart failure are hospitalized more than once for acute heart failure, and one in four patients is hospitalized again for 30 days after discharge. Up to 10% die. Effective initial treatment that can reduce re-hospitalization is important. Entresto is recommended as a standard treatment in domestic and foreign heart failure treatment guidelines, but it was difficult to use it initially in Korea as a limited standard. Professor Kang said, "Inpatients have not been able to use Entresto in the first round, but clinical studies have supported the importance of using drugs that can reduce mortality at the time of hospitalization," adding, "Now domestic inpatients are expected to use Entresto to significantly reduce re-entry and mortality." Entresto has also expanded its use in patients with a heart rate of more than 40% to less than normal (about 60%), which has been in unmet demand. Reduced hardness of ejection rate and some conservative patients can be treated with Entresto. Throughout this, Entresto has become the drug with the widest range of chronic heart failure indications in Korea. Entresto showed the greatest clinical effect in patients with a heart rate of 60% or less. Professor Cho Hyun-jae said, "When looking at the left ventricular ejection rate according to the quintile, it showed a consistent positive effect from less than 25% to less than 60%," adding, "9.6% of patients who preserved the ejection rate were progressing heart failure a year later. There have been many studies so far, but Entresto is expected to benefit from proving its effectiveness for the first time." Professor Cho then said, "Recently, SGLT-2 inhibitors have also shown some effects in preserving the ejection rate," adding, "Entresto and SGLT-2 inhibitors play different roles in three axes of heart failure treatment. Therefore, since the two drugs are not in a substitute relationship, but in a complementary relationship, standard treatment will move toward using Entresto and SGLT-2 together in the future, he added. Entresto surpassed 30 billion won in outpatient prescriptions within five years of its launch. Last year, prescriptions amounted to 32.3 billion won, up 37.3% from the previous year.
- Policy
- Will the separation of the Ministry of Health be promoted?
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- Yoon Seok-yeol's presidential transition committee seems to be discussing the necessity of separating the Ministry of Health and integrating and absorbing the MFDS in the process of discussing the reorganization of the government after the inauguration of the next government. As the pandemic era became commonplace due to COVID-19, the role of the health sector grew, and the medical community strongly urged the independence of the Ministry of Health and even academia insisted on the necessity of the Ministry of Health. According to Yoon Seok-yeol's transition committee and related academia on the 27th, various discussions are taking place over the next government organization, including the reorganization of the MOHW. Yoon's transition committee receives reports from each government department until the 29th, while keeping in mind the need for independence of the Ministry of Health along with the abolition of the Ministry of Gender Equality and Family. Some say that if the Ministry of Health becomes independent, the MFDS will also inevitably change its organization. With the independence of the Ministry of Health, there is a possibility that the MFDS will be integrated and absorbed as it was an organization under the MOHW in the past. If the Ministry of Health becomes independent from the MOHW, the number of personnel is about 400, and the MFDS should be integrated to strengthen and exist the ministry functions. In addition, the Ministry of Health may divide areas other than the food sector within the MFDS after independence from the Ministry of Health as there is a need to transfer food sector work within the MFDS. The medical community strongly agrees with the independence of the Ministry of Health. The Ministry of Health should be separated to respond to the public health crisis caused by the outbreak of infectious diseases and foster the health care sector. The KMA proposed several government reorganization plans to establish the Ministry of Health and manage the KDCA, the MFDS, and public health centers since Yoon was a presidential candidate. Independence of the Ministry of Health is also emphasizing the necessity of related academia. Kim Eun-joo, a professor of social science at Hansung University, appealed the need for independence from the Ministry of Health at a seminar hosted by the KAOS and the KAPAR21 on the 25th. Professor Kim Eun-joo said, "The MOHW should separate health functions and deploy the KDCA as a member of the Ministry of Health to strengthen the health and safety system based on expertise in the health sector." She said, "We need to establish an effective response system to infectious diseases such as COVID-19. The MFDS should also strengthen its health risk factor management function," she argued. Professor Kim argues that the MOHW should be divided into the Ministry of Health and that KDCA, the ministry in charge of quarantine, should be assigned as a member of the Ministry of Health. Kim Yoon-kwon, a senior researcher at KIPA, also mentioned the establishment of the new Ministry of Health, saying, "We need to redesign welfare and health functions to secure function completeness based on our expertise." The transition committee plans to collect expert opinions on independence of the Ministry of Health, reorganization of the KDCA, and integration of the MFDS. The plan to reorganize the government is expected to be outlined only after the transition committee's business report is completed and before the next government is launched.
- Company
- Four types of PE exemption drugs listed in one month…
- by Eo, Yun-Ho Mar 28, 2022 06:10am
- Coverage expansions of new drugs continue to be reported. In fact, four new drugs were successfully listed last month. According to industry sources, starting with Astellas’ ‘Xospata (gilteritinib)’ in March, Novartis’s ‘Kymirah (tisagenlecleucel),’ Roche’s ‘Rozlytrek (entrectinib),’ Bayer’s ‘Vitrakvi (larotrectinib)’ were listed as new drugs under the pharmacoevaluation exemption track. Despite the difficulties faced during discussions, all the drugs were successfully listed in the end. ◆'Xospata’ resolves the unmet needs in leukemia Xospata is the first treatment approved for FLT3mut+ relapsed/refractory Acute Myeloid Leukemia (AML). The drug, which was approved in March 2020, passed the Health and Insurance Review Service’s Drug Reimbursement Evaluation Committee on the 9th last year, and then started negotiations with the National Health Insurance Service in October of the same year, Although the parties were unable to reach an agreement within the set negotiation period (60 days) and extended the period once more to reach an agreement. Xospata was approved early this month. As a newly introduced treatment option, the public’s interest in on Xostapa’s reimbursement. In fact, the Korea Organization for Patient Group had delivered the opinion on the accelerated reimbursement of new drugs including Xostapa at a roundtable meeting with the MOHW’s Department of Pharmaceutical Benefits. ◆ GOV and company promptly works for the reimbursement of ' Kymriah' The reimbursement of the ultra-high-priced one-shot CAR-T therapy Kymriah has been successfully achieved with the efforts of the government, pharmaceutical company, and the patient. This drug started its reimbursement listing process with the MFDS approval through the approval-reimbursement evaluation linkage system in March last year. Although the agenda was listed for review by the Cancer Disease Deliberation Committee six months later, it was deferred at the time. As soon as the deferral was disclosed by the press, the Korean Alliance of Patient Organization issued a statement criticizing the government and the company. KAPO had previously criticized the delay in deliberations of the agenda by the Cancer Disease Deliberation Committee. As a result, Kymriah passed CDDC in the October of the same year. This was also the first day HIRA had disclosed the CDDC deliberation results. Also, Kymriah passed the review of the first Drug Reimbursement Review and Assessment Service meeting in 2022. And after extending negotiations once, the company succeeded in completing its negotiations and is set to be listed in April. Of course, this is a frustrating period of wait for the patients who long for reimbursement. However, considering the time usually consumed in the registration process for innovative new drugs in Korea, Kymriah’s reimbursement was quick. ◆'Rozlytrek' and 'Vitrakvi’ pave the road for tumor-agnostic drugs Rozlytrek and Vitrakvi had also overcome many obstacles. The two drugs passed the HIRA DREC review but their listing were deferred in the final stages, with the drug pricing negotiations being extended. As these drugs can be applied to many solid cancers that have specific genetic mutations, the authorities had difficulty applying one specific evaluation system and are judged that it will take a while for discussions to be made between the government and the pharmaceutical company. Rozlytrek and Vitrakvi are indicated for the treatment of patients that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy. In other words, the drugs can be used in most tumors with identified NTRK gene fusions. However still, conservative restrictions remain for the use of the drugs. The use of the two drugs was limited to cancer types mentioned in the NCCN guidelines.
- Policy
- Govn’t to introduce 460,000 courses of oral COVID-19 drugs
- by Kim, Jung-Ju Mar 28, 2022 06:10am
- Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters The government will be introducing 460,000 courses of oral COVID-19 treatments by the end of next month. In principle, Paxlovid will be prescribed first, and Lagevrio, which has recently been approved for emergency use, should be used for patients who are restricted from using Paxlovid, such as users of contraindicated drugs. On the 25th, COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head, Prime Minister Boo-kyum Kim) presided over a meeting in the videoconference room at the Sejong Government Complex with the central government departments, 17 metropolitan governments, and 18 cities and provinces on their COVID-19 vaccine/treatment development status and measures for support. According to Ki-il Lee, the first supervisor of the Central Disaster and Safety Countermeasures Headquarters who spoke at a briefing by the disease control and management authorities, the government has procured a total of 1,400,000 courses oral COVID-19 treatments and is in the process of introducing them sequentially. As of the 24th, 163,000 courses of Paxlovid (from Pfizer) have been introduced to Korea, 114,000 courses of which have been used on patients in Korea. On the criticism that Paxlovid is not being actively prescribed by managing medical institutions even if symptoms appear unless older adults in their 60s directly ask for prescriptions themselves, the authorities said they will check on it. Ki-il Lee said, “We will do our best to make sure that institutions that conduct rapid antigen testings can immediately prescribe the drugs to those aged 60 years or older and the immunocompromised. We have requested this from the presidents of 16 doctors’ associations in 16 cities and provinces. W We will do our best to allow prescriptions to be made as soon as possible." Also, the government is continuing negotiations to rapidly introduce oral COVID-19 treatments. Including the 20,000 courses introduced yesterday, the government is pushing for the early introduction of 460,000 courses of oral COVID-19 treatments by the end of April. On the 24th, the first 20,000 courses of Lagevrio were introduced in advance for use from tomorrow (26th). Lagevrio was granted Emergency Use Approval on the 23rd by the Ministry of Food and Drug Safety after conducting safety/efficacy reviews and expert consultations. In consideration of its EUA indication, the drug will be used ▲within 5 days of symptom onset, ▲on patients over the age of 60 or age of 40 with underlying diseases or immunocompromised ▲who have difficulty using existing treatments. The authorities will allow use of Lagevrio in patients who have difficulty using other treatments due to the use of contraindicating medications, etc., although Paxlovid will be first prescribed in principle. Patients with severe hepatic or renal impairment or patients taking drugs of specific ingredients (28 types (23 types that are approved in Korea)) are restricted from the use of Lagevrio. In addition, pregnant women and patients under the age of 18 are excluded from eligible subjects in consideration of the EUA condition set by the MFDS. The government said it is making every effort to ensure that the new oral COVID-19 treatment, Lagevrio, can be safely used in the field. In order to prevent prescriptions from being made to pregnant women, children, and adolescents and its safe use, the drug was registered in the DUR (Drug Utilization Review) system, and relevant systemic improvement measures were completed, such as adding drug information to the patient management information system. Also, the 'Treatment Use Guide (6th edition)' has been distributed to medical institutions to guide Lagevrio prescriptions in institutions, and pharmacies will be distributing detailed medication guides to those patients who have been prescribed Lagevrio. Meanwhile, the government announced that it would monitor the introduction and use of oral COVID-19 drugs, and will continue to compensate for serious adverse events that arise by applying the drug’s side effect damage relief procedures. The current side effects damage relief measures include a lump-sum death compensation (114 million won), funeral expenses (9.8 million won), disability lump-sum compensation (29 million won to 114 million won), and hospitalization & treatment expenses (up to 20 million won). Medical institutions, pharmacies, patients, etc. can report side effects that occur after the use of drugs to the Korea Institute of Drug Safety and Risk Management (report online at www.drugsafe.or.kr) or receive related consultations.
- Policy
- The gov's all-out efforts to promote EUA for overseas drugs
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- The government will make all-out efforts to expand the total amount of supply by expanding the production and import of regular medicines such as antipyretic painkillers and cold medicines used to alleviate COVID-19 symptoms. It will even review the emergency introduction of foreign drugs with the same composition as domestic licensed items, quickly review them to prevent disruptions in production due to administrative procedures such as permits, and continue administrative support. The government expressed its willingness to make active efforts with the pharmaceutical industry to stabilize the supply of COVID-19, while also asking the medical and pharmaceutical sectors for cooperation such as prescribing an appropriate amount of solid drugs instead of syrup. Park Hyang, head of the Central Disaster and Safety Countermeasures Headquarters, made the announcement at a regular briefing on the 23rd. As a result of receiving a report from the MFDS on the supply and demand status and action plans for COVID-19, the Central Disaster and Safety Countermeasures Headquarters decided that supply needs to be stabilized. The shortage of some products of antipyretic pain relievers and cold medicines used to alleviate COVID-19 symptoms continues. Accordingly, the government will expand the total supply of COVID-19 medicines. Specifically, it expands production and imports and encourages rapid shipment. It will consider promoting the emergency introduction of overseas drugs with the same composition as domestic licensed products. The government plans to do its best to prevent disruptions in production by providing support for rapid processing such as changing the raw materials and manufacturing plants of standing medicines, quick import approval of drugs and raw materials contained in cold medicines, and convenience of other administrative procedures. It also asked the medical and pharmaceutical sectors to prescribe an appropriate amount of prescription and a solid drug rather than a syrup drug. The government announced its intention to maintain and strengthen support for clinical trials of COVID-19 vaccines and treatments. Currently, eight vaccine companies and 17 treatment companies (18 candidate substances) are conducting clinical trials in Korea. SK Bioscience vaccine has completed recruiting and inoculating phase 3 clinical participants with the aim of completing development in the first half of this year. Subsequently, the procedure for confirming the efficacy of the vaccine through sample analysis is in progress. The treatment is developing an additional antibody treatment (Celltrion) that can respond to mutant viruses, and Ildong Pharmaceutical is jointly conducting clinical trials by securing domestic copyright for Shionogi's developed and edible treatments. The government announced that it is supporting the development of domestic COVID-19 vaccines and treatments with all its might by operating the pan-government support committee for the development of COVID-19 treatments and vaccines. The government said, "For the rapid development of treatments and vaccines, clinical trials are more important than anything else," adding, "We ask the public to actively pay attention to and participate in clinical trials."
- Company
- Sanofi Launches 3rd Generation Antihistamine Alllegra
- by Nho, Byung Chul Mar 28, 2022 06:10am
- Sanofi Korea announced on the 23rd that it released Allegra 120mg, an allergic rhinitis treatment with 3rd generation antihistamine ingredients, in February. Most 3rd generation antihistamines are Rx drugs, which can only be taken after prescription at clinics, but Allegra can be purchased without prescription at pharmacies with permission from OTC for a dose of 120mg. Fexofenadine, the actvie ingredient of Alllegra, is a third-generation antihistamine component. Antihistamines are classified from 1st to 3rd generations according to the development order, and have gradually improved in terms of effects and side effects as generations evolve. The newly launched Alllegra is a next-generation ingredient that improves/complementes the advantages and disadvantages of first- and second-generation antihistamines, and it is a third-generation antihistamine allergy drug that is effective quickly, reduces sleepiness, and lasts 24 hours. Allegra is 10 tablets per pack, and one tablet (120 mg) can be taken once a day with sufficient water before meals. It is expected to improve the quality of life of busy modern people such as drivers, office workers, and students who usually suffer from allergic rhinitis, as the effect is rapidly expressed within 60 minutes on average and the effect lasts for 24 hours. In addition, there is no interaction through hepatic metabolism, so patients taking other drugs can also take them according to the advice of medical experts. Allergic rhinitis, classified as a chronic disease, is mainly caused by allergic antigens such as house dust, mold, cockroaches, and pollen, or by rapid temperature changes, air pollution, and pet hair, and is classified as the most common disease type worldwide. Symptoms of allergic rhinitis are similar to colds, such as stuffy nose, clear runny nose, sneezing, and itchy eyes and nose. Advertising for the new Alllegra will be on-air through TV and digital platforms from March. Under the theme of house dust, pet fur, change of seasons, and air pollution, the advertisement plans to actively promote allergic rhinitis and improve the quality of life through Allegra, a third-generation antihistamine drug, even in various daily situations.
- Policy
- Kymriah's benefit standard has been established
- by Lee, Tak-Sun Mar 25, 2022 05:48am
- The worldChimeric antigen receptor-T cell therapy, which can be effective only once by using cancer patient T cells, is expected to be given to patients after receiving health insurance benefits for the first time in Korea from April. Novartis' Kymriah will enter the benefit range a year after being approved in Korea. The HIRA announced that it will conduct an inquiry on the "Amendment of Public Notice according to Drugs Prescribed and Prescribed to Cancer Patients" from the 24th to the 30th, including the establishment of Kymriah's standards. The amendment will take effect on April 1 unless there is a disagreement. In this amendment, standard was established to allow Kymriah to be administered to an adult (DLBCL) Diffuse Large B-cell Lympoma and B-cell acute lympneumonia (ALL), one of the non-Hodgkin lymphoma. Specifically, after two or more systemic treatments, it is newly established as a tertiary or more monotherapy for DLBCLs in adults who are recurrent or refractory. The recognition period is once in a lifetime per patient, and should be administered by a doctor with sufficient knowledge and experience in chemotherapy at medical institutions capable of responding to emergencies in preparation for unexpected side effects of CAR-T cell therapy. There was a condition that data on the status of medical care benefits should be submitted to the director of the HIRA. Accordingly, a form related to follow-up management should be submitted to the director of the HIRA at the time of administration of Kymriah, 6 months after administration, and 12 months after administration. It is also recognized if Kymriah is administered in post-transplantation recurrence or secondary recurrence and subsequent recurrence or refractory B-cell acute lymphatic leukemia (ALL) treatment in children and young adults under the age of 25. The administration stage should be secondary or tertiary or higher. It can also be administered under the direction of a medical institution suitable for treatment and an educated doctor, and the recognition period is once in a lifetime per patient. Kymriah is the world's first approved CAR-T treatment. CAR-T treatment is an immune cell therapy anticancer drug made by combining genetic information that expresses chimeric antigen receptors specific to cancer cells in patients' T cells. It is in the spotlight as a next-generation anticancer drug that can have a high effect with just one administration. However, insurance authorities have been agonizing over the difficulty of accessing patients due to high costs. Kymriah passed Drug Benefit Evaluation Committee of the HIRA in January and has been negotiating drug prices with the NHIS. Roche's Rozlytrek (Entrectinib), and Bayer's Vitrakvi (Larotrectinib Surfate) also included a new standard. Rozlytrek is newly established as a primary treatment for solid cancer in adults and children over 12 years of age with neurotic tyrosine receptor kinase (NTRK) gene fusion without known acquisition-resistant mutations. Vitrakvi is similar. However, there is no age limit for children. Non-Hodgkin lymphoma combination therapy (secondary or higher) of Rituximab+Revlimid and combination therapy of Bortezomib +Revlimid + Dexamethasone for newly diagnosed for multiple myeloma is newly established for multiple myeloma.
- Company
- Antengene’s first new drug Xpovio lands in hospitals
- by Eo, Yun-Ho Mar 25, 2022 05:48am
- ‘Xpovio, the first drug introduced by the Chinese pharma company Antengene, has landed in general hospitals. According to industry sources, the company’s anticancer drug Xpovio (Selinexor) has passed the review of drug committees (DCs) at 4 of the Big 5 tertiary hospitals - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St.Mary’s hospital, Seoul Asan Medical Center (AMC) – and has been added for prescriptions through an emergency DC at the Severance Hospital. Xpovio, which had been designated as an orphan drug and then approved in August last year, is a drug with a new mechanism of action that selectively inhibits the nuclear export protein XPO1. The drug was approved for two indications: ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment. XPO1 inhibitors are expected to be used to improve outcomes of various diseases in combination with other regimens (drugs) in the future. The National Comprehensive Cancer Network (NCCN) guidelines currently recommend 5 treatment regimens including Xpovio. Most multiple myeloma recurs and is refractory to treatment, and diffuse large B-cell lymphoma that has failed systemic treatment also has less chance of being cured or achieving long-term progression-free survival every time the disease progresses after treatments. As a result, a dire need has existed for a more safe and effective treatment method in relapsed and/or refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. However, experts expect that it will take some more time for the drug to be listed for reimbursement. Xpovio had undergone review by HIRA’s Cancer Disease Deliberation Committee in January but had failed to set reimbursement standards. The reason for the failure is known to be that the company wasn’t able to satisfy ‘the number of A7 country released’ requirement. Therefore, the company needs to wait for the drug’s results in other countries to attempt reimbursement in Korea. Meanwhile, the drug’s efficacy was demonstrated through two Phase II trials – the STORM and SANDAL trials. In the STORM study, Xpovio achieved an objective response rate (ORR) of 26% and a clinical benefit rate (CRB) of 39.9% in combination with dexamethasone in patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies In the SADAL study that was conducted on patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment, Xpovio as monotherapy had achieved an ORR of 28.3% and a CR of 11.8%.
