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- 2026-03-19 01:38:07
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- Celltrion, begins development of Insulin pen biosimilar
- by An, Kyung-Jin Jun 08, 2020 06:11am
- View of CelltrionCelltrion is working with a domestic medical device company to develop an insulin biosimilar. The goal is to secure cost competitiveness and lower dependence on imports by developing a pen-type insulin injection for the first time in Korea. Celltrion’s insulin pipeline was selected as a state-designated project by the Korea Evaluation Institute of Industrial Technology (KEIT). The four-year development will require a total budget of ₩4 billion, of which ₩3 billion will be supported by the government. The two companies focused on developing a pen-type injection that can be automatically administered up to 80 units once. The intention is to commercialize domestic insulin pen-type injections using domestic materials. Celltrion is in charge of insulin biosimilar development and clinical trials, and Poonglim Pharmatech plays a role in charge of developing an auto pre-filled pen type injector that can be used by filling in biopharmaceuticals developed by Celltrion. It will be commercialized by 2025 through four years of research and development. Currently, 96 percent of the global insulin market is taken by Sanofi, Eli Lilly and Novo Nordisk. Biosimilar products are also sold only by Sanofi and Lilly. In the domestic insulin market, there were many opinions that the localization of the product was urgent as Novonordisk occupied 45%. The national assignment project evaluation committee is also known to give a high score to reduce the dependence on imports if 'Korea's No. 1' product with quality and cost competitiveness is released in consideration of such market conditions. Half out of an estimated 463 million global diabetic patients use pen injectors, Celltrion said, adding that the market is annually growing by 9 percent. By 2023, the pen insulin market size is predicted to hit ₩37 trillion. An official from Celltrion said, “The selection of the target for this national project is the result of the recognition of the technological development innovation of both companies and the know-how and development of the market in the future.” "We expect diabetic patients around the world to benefit from more convenient treatments at lower cost."
- Company
- Unpredictable Cancer Committee make all kinds of decisions
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- The expression on all the pharmaceutical companies accepting the final outcome varied as the meeting concluded. But for sure, no one had a perfect game. On June 3, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee was convened to discuss two immunotherapies, two poly ADP-ribose polymerase (PARP) inhibiting targeted therapies and two multiple myeloma treatments. ◆ Keytruda and Opdivo The decision on MDS’s Keytruda (pembrolizumab) has been deferred yet again. The Committee reviewed granting reimbursement on Keytruda’s five indications, including first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In the April meeting finally convened after being postponed twice due to COVID-19, the Cancer Committee deferred the decision on the immunotherapy. Although not required, the multinational company submitted an economic evaluation data and financial impact solution plan on using the immunotherapy as a first-line treatment (mono and combination therapy) in patients with non-small cell lung cancer (NSCLC) to better express its commitment to receive the extended reimbursement. Regardless, the committee did not give a satisfying answer, explaining that they did not have sufficient time to review properly. Bristol Myers Squibb (BMS) and Ono’s Opdivo (nivolumab), on the contrary, gave up on the lung cancer indication and won the benefit in Yervoy (ipilimumab) combination therapy. Apparently, BMS and Ono have also submitted an economic evaluation data to secure the coverage on Opdivo plus Yervoy combination therapy. In April, the Cancer Committee cleared the reimbursement on Opdivo for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but denied the indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy. And at the latest meeting, the committee gave a nod to Opdivo’s indication to treat renal cell carcinoma as a first-line therapy. After receiving the first reimbursement as a second-line therapy in patients with NSCLC in September 2017, Opdivo has taken three years to pass the Cancer Committee. ◆Lynparza and Zejula Without a surprise, the Cancer Committee’s answer to PARP inhibitor’s indication on BRCA-negative patients was ‘no.’ AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib) were half-successful in the end. The Cancer Committee reviewed Lynparza’s tablet indicated to as a maintenance therapy following a first-line therapy in patients with BRCA-mutated advanced ovarian cancer, second or later-line treatment in platinum-sensitive patients with relapsed high grade serous epithelial ovarian, treatment in patients with HER2-negative metastatic breast cancer. The committee recognized the need for first and second-line maintenance therapy in BRCA-mutated ovarian cancer, but ruled out mBRCA-negative patients included in the second-line therapy indication. Also, the committee seemed skeptical of the breast cancer indication. Zejula also had a similar outcome. The review was on using the drug as maintenance therapy of patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. The government is still conservative about an anticancer treatment indicated to treat ‘all comers.’ ◆ Revlimid and Pomalyst Multiple myeloma treatments seem to be struggling with maintenance therapy. Deferred by the Cancer Committee last September, Revlimid (lenalidomide) once again requested a review on extended coverage on a maintenance therapy to prevent relapse in patients who had stem cell transplantation, which was not granted. The combined company of Bristol Myers Squibb (BMS) and Celgene offered a financial impact solution plan for the coverage on the maintenance therapy indication, but the committee did not change its mind. However, the committee green-lit the reimbursement on Pomalyst (pomalidomide) as a second-line therapy, extended from the current coverage on third-line therapy. Specifically, the approval was granted on the Pomalyst, Velcade (bortezomib) and dexamethasone combination therapy in patients with multiple myeloma, who have previously received one or more treatment including Revlimid. With the latest approvals, BMS and Celgene combined have received approval on two out of three items in the first Cancer Committee meeting held since their merge.
- Company
- General Hospitals to prescribe AbbVie Skyrizi with coverage
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- General hospitals are ready to prescribe now listed Skyrizi, the fourth interleukin inhibitor in the Korean market. Pharmaceutical industry sources reported drug committees (DC) at Korea University Ansan Hospital, Soonchunhyang University Bucheon Hospital, Design Hospital, Gangnam Severance Hospital, Dankook University Hospital, Hallym University Kangnam Sacred Heart Hospital and Korea University Guro Hospital have cleared interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of patients with severe psoriasis. Skyrizi has been listed for National Health Insurance (NHI) reimbursement from June 1. The coverage would be granted to patients with chronic psoriasis at a severe level expressed for over six months, who show symptoms of plague psoriasis on 10 percent and more of their body surface area, score 10 or higher on Psoriasis Area and Severity Index (PASI) and demonstrate no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine or cannot maintain the therapy due to adverse reaction, or demonstrate no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. From now on, Korea’s interleukin inhibitor drug market would be divided among four competitors including Novartis’ IL-17A inhibitor Cosentyx (secukinumab), Lilly’s IL-17 inhibitor Taltz (ixekizumab) and Janssen’s IL-23 inhibitor Tremfya (guselkumab), as well as Skyrizi. All four drugs have been first approved as a psoriasis treatment, but they are respectively expanding their indications in autoimmune disease sector. Professor Youn Sang Woong of Department of Dermatology at Seoul National University Bundang Hospital said, “Skyrizi has outstanding benefit in skin condition improvement, safety and convenience, which would greatly help patients to achieve their most wanted goal of maintaining clean skin for a long time.” Skyrizi has confirmed efficacy and safety in treatment through four clinical trials including UltIMMa-1, UltIMMa-2, IMMvent and IMMhance studies. The UltIMMa-1 and UltIMMa-2 studies found 75 percent of patients using Skyrizi have reached 90 percent skin improvement (PASI 90) at week 16, and 36 percent and 51 percent of patient groups in respective studies have shown 100 percent skin improvement (PASI 100). Analyzing the patients who received Skyrizi during the two trials, the treatment effect in most of the patients who demonstrated PASI 90 and PASI 100 has been maintained even after a year.
- Company
- Immunotherapy Keytruda faces Cancer Committee once again
- by Eo, Yun-Ho Jun 05, 2020 06:09am
- An immunotherapy Keytruda would be standing before the Cancer Deliberation Committee once again. On June 3, Keytruda (pembrolizumab) would be deliberated by Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee again, although the committee deferred the decision in a meeting finally held on Apr. 29 after COVID-19 postponing the schedule twice. The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion. But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision. Accordingly, MSD has revised the financial impact resolution plan once again for technically the last negotiation. If Keytruda fails to pass the Cancer Committee this time, the coverage extension discussion on the immunotherapy would highly likely to get pushed aside indefinitely. Keytruda was listed for the first time in August 2017 through a combination of refund and expenditure cap type risk sharing agreement (RSA) based on the PD-L1 expression rate as a standard. The drug is even trying to replace existing first-line chemotherapy option with the immunotherapy as a monotherapy. This holds a significant meaning. If the coverage expansion is granted, then a patient diagnosed with stage IV lung cancer, not subject for targeted therapy with EGFR mutation, could be prescribed with Keytruda.
- Company
- Janssen revs up 2 new global trials on lazertinib
- by An, Kyung-Jin Jun 04, 2020 06:14am
- Janssen’s novel anticancer treatment lazertinib licensed out from Yuhan is initiating a new global clinical trial. Prior to a global phase 2 trial, the multinational company is accelerating the investigational drug’s commercialization process with other phase 1 trials. According to a clinical trial registration website ‘clinicaltrials.gov’ by the U.S. National Institutes of Health (NIH) on June 2, Janssen has registered two global phase 1 trials attached to lazertinib. One is an open-label study to investigate absorption, metabolism and excretion of administered 14C-lazertinib and another is assessing effects of CYP450 3A4 inhibitor itraconazole or CYP450 3A4 inducer rifampin on lazertinib. Both trials are testing the drug in healthy adults. Lazertinib, in development as a non-small cell lung cancer (NSCLC) treatment, aims to evaluate its tolerance, safety and pharmacokinetics. The two trials are scheduled to conclude in coming November, but they have not started calling for participants. In 2018, Yuhan licensed out a third generation epidermal growth factor receptor (EGFR) targeted therapy lazertinib to Janssen Biotech. The novel drug is evaluated to have potency to be a second-line treatment in NSCLC patient who developed T790M mutation after taking existing EGFR targeted therapy or a first-line treatment in NSCLC patient who has EGFR mutation. Janssen is currently focused on investigating the potency of combining lazertinib and a bispecific antibody targeted therapy amivantamab that the company started developing after licensing in lazertinib. A large-scale global clinical trial evaluating the amivantamab plus lazertinib combination therapy has started by calling for participants from September last year. By early this year, the trial participant size increased from 400 to 460 and moved up the end point to June 2022. The trial would proceed to next stage when the recommended phase 2 dose (RP2D) is decided. Johnson & Johnson (J&J) has appointed amivantamab and lazertinib as a promising pipeline of the pharmaceutical sector and drew up a blueprint to complete the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) by 2023. The latest registration of the clinical trials could be interpreted as the company consolidating their commitment to commercialize lazertinib. Yuhan, on the other hand, could receive massive milestone payment again within this year with the combination therapy’s phase 2 trial in full motion. In November 2018, Yuhan has signed lazertinib license-out deal with Janssen Biotech and received an upfront payment of USD 50 million (approximately 55 billion won). The Korean company recently received milestone payment of 35 million dollars for the amivantamab combination therapy phase 2 trial. 18 months into the deal, the company generated 85 million dollars. When lazertinib is successfully commercialized, the Korean company would receive up to 1.25 billion dollars for achieving milestones.
- Company
- 3 out of 10 executives, worries about poor performance
- by Chon, Seung-Hyun Jun 03, 2020 06:40am
- The executives working at the pharmaceutical company pointed out the poor performance after COVID-19 outbreak. Most people pointed out that the company should reduce its performance targets to minimize damage to COVID-19. On the 21st anniversary of its founding, Dailypharm conducted a survey of “Post COVID-19 Crisis Response Strategy” by 725 executives from pharmaceutical companies. Pharmaceutical executives responded to the question of what was the biggest inconvenience after the COVID-19 incident, with 228 respondents (31.4%) responding to poor performance due to face-to-face reduction. As patients are reluctant to visit medical institutions after the COVID-19 crisis, there is growing concern over the decline in prescription drug sales in pharmaceutical companies. In addition, pharmaceutical companies have expanded telecommuting since the spread of COVID-19, but concern about poor performance due to negligent account management has emerged as the biggest concern. 25% of respondents (181 people) pointed out anxiety about job cut. This means that there are many executives who are concerned about the reduction of manpower due to the restructuring due to changes in the way they work, such as expanding non-face-to-face work. Many respondents pointed out that the inefficiency of work due to telecommuting (17.9%), the strengthening of the company's surveillance and distrust of the boss (13.0%), and the deterioration of work and life balance (12.7%) due to the disappearance of the boundary between work and privacy were uncomfortable. Regarding the cost reduction plan to minimize the damage to COVID-19, 65.1% (472 people) of the pharmaceutical executives answered that they adjusted their sales amount such as lowering their targets. In COVID-19 crisis, it is the view that, in a situation where the economic recession is realizing, the crisis must be overcome by adjusting the company-wide goals. 8% (203) answered that they should cut costs by reducing operating expenses such as salary or marketing expenses. Over 10% of respondents said that they should consider reducing manpower (13.8%) and reducing investment (11.2%). Pharmaceutical executives agreed with COVID-19 to break away from traditional business methods. Regarding the direction of reorganization of sales and marketing strategies in the post-corona era, 40.3% (292 employees) of pharmaceutical companies said that they should strengthen online sales and marketing. As a result of the COVID-19 crisis, it is recognized that shrinking face-to-face sales and activating non-face-to-face sales are required, and strengthening IT-based face-to-face sales strategies is essential. 29.8% (216 people) said that it is necessary to find marketable products. Pharmaceuticals executives recognized that post-corona era workforce restructuring is expected. 61.1% (443) responded to the question that asked about opinions on the decline in jobs in the pharmaceutical industry after the COVID-19 crisis. In fact, 14.6% of executives predicted that the jobs in the pharmaceutical industry would drop significantly. 57% (413 people) said that the number of sales jobs would decrease the most. Also, 28.7% of respondents predicted that jobs would be reduced in office work such as personnel and management, which is expected to shrink due to the activation of non-face-to-face work. In the post-corona era, 40.1% of the respondents said that jobs in online IT-based jobs would increase. Also, 22.6% of respondents pointed to the expansion of marketing jobs. Pharmaceuticals executives also expressed negative views on the reorganization of the business method in the post-corona era. When asked whether to reduce face-to-face operations after COVID-19, more than half, 54.5% (395) said they could do as before. Although socially reluctant to face-to-face business, there are many conservative views that meeting with a doctor or pharmacist and conducting sales activities is more helpful for performance. According to the survey, 38.8% of respondents said that face-to-face sales should be reduced. About half of the executives (50.9%) predicted that the pharmaceutical industry would settle for telecommuting or flexible work. In the post-corona era, the reorganization of the way of working is a demand of the times. The employees of pharmaceutical companies expected that telecommuting or flexible work would increase work efficiency. 44.1% of respondents said that telecommuting or flexible work would improve work efficiency. This data is the result of a survey conducted by Dailypharm on 725 executives of pharmaceutical companies.
- Company
- Cancer Committee to review 3 signature drugs by BMS-Celgene
- by Eo, Yun-Ho Jun 03, 2020 06:25am
- On June 3, the Cancer Deliberation Committee is to review granting coverage on key products by the combined company of Bristol Myers Squibb (BMS) and Celgene. Celgene’s multiple myeloma pipelines—Revlimid (lenalidomide) and Pomalyst (Pomalidomide)—and BMS’ immunotherapy Opdivo (nivolumab) plus Yervoy (ipilimumab) combination are on today’s agenda. Revlimid and Pomalyst each targeting different goals Revlimid, despite the Cancer Committee deferring the drug in last September, is trying the committee again with coverage extension as a maintenance therapy to prevent relapse in patients who had stem cell transplantation. Unlike last time, Celgene has apparently prepared more accommodating financial solution to offer. From a financial standpoint, Revlimid’s maintenance therapy does not strain NHI so much. Research data claims a patient who did not receive maintenance therapy after the transplantation comes to initiate the second-line therapy quicker than the patients who have. And the following second-line therapy uses at least two drugs combined, but the U.S. National Comprehensive Cancer Network (NCCN) guideline and European Society for Medical Oncology (ESMO) recommend triple therapy including Revlimid. The recommended triple therapy is a combination of comparatively high-cost drugs like Revlimid, Kyprolis (carfilzomib), Empliciti (elotuzumab), Ninlaro (ixazomib) and Darzalex (daratumumab). Technically, using a single therapy for maintenance to delay the relapse would ultimately delay the high-cost triple therapy. Moreover, the already-reduced pricing of off-patent Revlimid would be additionally reduced when the reimbursement is extended to cover the maintenance therapy. Pomalyist, on the other hand, has applied for coverage review as a second-line therapy, in addition to its coverage on third-line therapy. The committee would review the combination therapy consisting of Pomalyst, Velcade (bortezomib) and dexamethasone for patients with multiple myeloma, who have previously received one or more treatment including Revlimid. Opdivo and Yervoy combination therapy tries renal cell carcinoma treatment Opdivo is focusing on a combination therapy with Yervoy. During the April Cancer Committee meeting, the reimbursement on Opdivo has been cleared for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy have failed. But the committee would review Opdivo as a first-line therapy for renal cell carcinoma. Ono Pharmaceutical and Opdivo have technically given up on reimbursement on the non-small cell lung cancer indication after having a preliminary meeting with the government in May last year. But now the company has shifted its focus to different indications. At the moment, Sutene (sunitinib), Nexavar (sorafenib) Torisel (temsirolimus), Votrient (pazopanib) and Avastin (bevacizumab) are available for first-line treatment in patients with renal cell carcinoma, but the reimbursement is granted when choosing one among all options except for Avastin. The CheckMate-214 study has confirmed the Opdivo plus Yervoy combination therapy significantly improving the overall survival of the participating patients regardless of PD-L1 expression against the sunitinib group.
- Company
- AbbVie’s psoriasis drug Skyrizi NHI listed from June 1
- by Eo, Yun-Ho Jun 03, 2020 06:25am
- Another interleukin inhibitor has been listed for National Health Insurance (NHI) reimbursement. AbbVie Korea announced the Korean health authority is providing healthcare reimbursement on severe psoriasis treating interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) from June 1. The coverage would be granted to patients with chronic psoriasis at a severe level expressed for over six months, who show symptoms of plague psoriasis on 10 percent and more of their body surface area, score 10 or higher on Psoriasis Area and Severity Index (PASI) and demonstrate no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine or cannot maintain the therapy due to adverse reaction, or demonstrate no reaction despite receiving photochemotherapy or UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. Psoriasis is an immune-mediated disease resulted by abnormal activity of the body’s immune system. The disease causes a red, peeling rash spreading across the body. Apparently, patients with moderate to severe level of psoriasis, whose 10 percent of body surface area is covered with the rash and exfoliated sheets of skin, mentally suffer from other people’s social bias and misunderstanding as an infectious disease. According to data disclosed last year by National Health Insurance Service (NHIS), approximately 160,000 people in Korea have visited hospital in last five years due to psoriasis, and 20 percent of those people, or about 30,000, are struggling with severe case of psoriasis. Professor Youn Sang Woong of Department of Dermatology at Seoul National University Bundang Hospital said, “Skyrizi has outstanding benefit in skin condition improvement, safety and convenience, which would greatly help patients to achieve their most wanted goal of maintaining clean skin for a long time.” Skyrizi has confirmed efficacy and safety in treatment through four clinical trials including UltIMMa-1, UltIMMa-2, IMMvent and IMMhance studies. The UltIMMa-1 and UltIMMa-2 studies found 75 percent of patients using Skyrizi have reached 90 percent skin improvement (PASI 90) at week 16, and 36 percent and 51 percent of patient groups in respective studies have shown 100 percent skin improvement (PASI 100). Analyzing the patients who received Skyrizi during the two trials, the treatment effect in most of the patients who demonstrated PASI 90 and PASI 100 has been remained even after a year.
- Company
- 'Champix' sales rebounded 13% in one year
- by Kim, Jin-Gu Jun 03, 2020 06:25am
- ChampixPfizer's anti-smoking supplement Champix (Varenicline) has been successful in rebounding sales. It increased by 13% compared to the first quarter of last year. It is an analysis that it benefited from winning the patent dispute with generics. According to the drug analysis agency IQVIA on the 29th, the sales of Champix in the first quarter was ₩6.9 billion. This is a 13% increase from the first quarter of 2019, compared to ₩6.1 billion. In terms of quarterly sales, it has increased significantly since the second quarter of last year. It is analyzed as the result of winning the patent dispute with generics. Champix' salt modified drug was first released in November 2018. However, when the supreme court ruled in January 2019 that patent evasion of salt-modified drug was illegal in Solifenacin formulations, most of them were discontinued. In December of the same year, for the same reason as the judgment of Solifenacin, it was illegal to release the drug before changing the substance patent for the Champix salt modified drug. As a result of this ruling, domestic pharmaceutical companies' marketing has been suspended. However, from 3Q this year, it will resume competition with generics. This is because the material patent of Champix will expire on July 19th. This is because it is possible to re-engage generics that have previously avoided or invalidated the salt patent of Champix. It is estimated that 37 pharmaceutical companies are waiting for patent expiration with 85 items on the 29th. In addition, the application for permission to change salts has recently increased. Since January of this year, there have been a total of 12 items for the application of permission to change salts for Champix. Champix quarterly sales trend (₩100 million, data IQVIA) Although Champix sales rebounded, they haven't recovered to the extent of regaining the glory of the past. Champix once had quarterly sales of ₩21.4 billion (first quarter of 2017). Compared to that time, it is only a third. This is because the number of participants in the anti-smoking support project has steadily decreased and the drug price has been cut by nearly 40%. In November 2018, the NHIS lowered the drug price from ₩1,800 to ₩1,100.
- Company
- New anticancer drugs by Bayer have been approved in Korea
- by Eo, Yun-Ho Jun 02, 2020 06:09am
- Two new drugs of Bayer's anticancer drugs will enter the domestic market. Androgen Receptor Inhibitor (ARi), Nubeqa (Darolutamide), treatment for nmCRPC and Orbital Selective Tropomyosin Receptor Kinase (TRK) inhibitor, Vitrakvi (Larotretinib) was recently approved by the MFDS. Nubeqa is an androgen receptor inhibitor with a unique chemical structure. It binds to androgen receptors and suppresses the growth of prostate cells through strong antagonism. This domestic permit is based on ARAMIS, a phase III clinical study that compared and evaluated the effectiveness and safety of Nubeqa and placebo controls in combination with androgen deprivation therapy (ADT). The study's main evaluation item, Metastasis-free Survival Period (MFS), was 40.4 months in Nubeqa and ADT combination groups, and demonstrated a significant improvement compared to 18.4 months in the placebo and ADT combination groups. Death risk was found to have decreased by 31% In addition, Vitrakvi has a high probability of severe morbidity during local, metastatic, or surgical resection among adult and pediatric patients who have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquisition-resistant mutation, and proceeds after existing treatments (or treatment regimens). It can be used for the treatment of patients with solid cancer who do not have a suitable treatment available or are currently available. The efficacy effect of Vitrakvi was approved on the basis of the overall response rate, and no clinical trials have demonstrated clinical benefits such as increased survival. This domestic permit includes clinical trials for adult and pediatric NTRK gene fusion advanced solid cancer patients (Phase I for adults 18 years of age and older, NAVIGATE Phase II for adults and children over 12 years of age, and primary CNS tumors). It is based on SCOUT Phase I/II trial in pediatric patients from 1 month to 21 years of age). According to the efficacy evaluation of a total of 55 patients in which NTRK gene fusion was confirmed from three clinical studies, Vitrakvi achieved an objective response rate (ORR) of 75% and a partial response rate (PR) of 53% in various carcinomas (soft tissue sarcoma, infantile fibrosarcoma, salivary gland cancer, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor)
