|
| Wednesday, 23 June 2021, 14:20 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
TOKYO, June 23, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor "Tazverik Tablets 200 mg" (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable).
This approval is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 206)(1) in Japan conducted by Eisai and other studies(2) conducted by Epizyme, Inc. (Headquarters: Massachusetts, United States) outside Japan. Study 206 enrolled patients with EZH2 gene mutation- positive, primarily follicular lymphoma, who had relapsed or were refractory. The primary endpoint of this study was objective response rate (ORR), and secondary endpoints included safety. This study achieved the primary endpoint target and exceeded a prespecified tumor response threshold with statistical significance: ORR in patients with EZH2 mutation-positive relapsed or refractory follicular lymphoma (n=17) was 76.5% (90% confidence interval (CI): 53.9-91.5) as measured by independent review.
Treatment-emergent adverse events (incidence of 25% or more) observed in this study were dysgeusia (52.9%), nasopharyngitis (35.3%), lymphopenia (29.4%) and blood creatine phosphokinase increased (29.4%). Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered "Tazverik" until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the MHLW.
Created by utilizing Epizyme's proprietary product platform, "Tazverik" is a first-in-class small molecule inhibitor of the epigenetic enzyme EZH2. It is one of the histone methyltransferases in the epigenetics- related protein group, and is thought to regulate the expression of cancer-related genes and suppress the growth of cancer cells by specifically targeting EZH2, which contributes to the cancer growth process.(3) Eisai is responsible for the development and commercialization of this agent in Japan, while Epizyme, Inc. is responsible for all regions outside of Japan. In the United States, "Tazverik" received accelerated approval for the indication of epithelioid sarcoma in January 2020, and follicular lymphoma in June 2020.
Follicular lymphoma is a low-grade B-cell lymphoma that accounts for 10-20% of non-Hodgkin's lymphomas. Follicular lymphoma is generally indolent and sensitive to chemotherapy. However, development of a new treatment strategy is required for follicular lymphoma which still remains difficult to cure, as recurrence often occurs repeatedly. 7-27% of follicular lymphomas are reported to have gain-of- function mutations in the EZH2 gene,(4),(5) and it is estimated that there are approximately 600 to 2,400 patients with follicular lymphoma with EZH2 gene mutations in Japan. A companion diagnostic test for EZH2 gene mutations, "cobas EZH2 Mutation Test" by Roche Diagnostics K.K. (Headquarters: Tokyo) was approved in May 2021.
Eisai aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals, by delivering "Tazverik" as a new treatment option for EZH2 gene mutation-positive follicular lymphoma.
Media Inquiries:
Public Relations Department
Eisai Co., Ltd.
+81-(0)3-3817-5120
(1) Shinya Rai, et al. Phase 2 Study of Tazemetostat in Japanese patients with Relapsed or Refractory EZH2 mutation-positive B-cell Non-Hodgkin's Lymphoma. AACR Meet. 2021, CT176.
(2) Franck Morschhauser, et al. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. The Lancet Oncology. 2020 Nov; 21(11):1433-1442.
(3) Sarah K. Knutson, Satoshi Kawano, Yukinori Minoshima, et al. Selective Inhibition of EZH2 by EPZ-6438 Leads to Potent Antitumor Activity in EZH2-Mutant Non-Hodgkin Lymphoma. Molecular Cancer Therapeutics. 2014 Apr; 13(4):842-854.
(4) Csaba Bodor, et al. EZH2 mutations are frequent and represent an early event in follicular lymphoma. Blood, 2013 Oct; 122(18), 3165-3168.
(5) Ryan D. Morin, et al. Somatic mutation of EZH2 (Y641) in Follicular and Diffuse Large B-cell Lymphomas of Germinal Center Origin. Nat Genet. 2010
February; 42(2): 181-185.
Topic: Press release summary
Source: Eisai
Sectors: Healthcare & Pharm
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Dec 23, 2024 16:22 HKT/SGT |
|
Fujirebio and Eisai Enter into Memorandum of Understanding for Joint Research and Social Implementation of Blood-based Biomarkers in the Field of Neurodegenerative Diseases |
| Dec 11, 2024 13:45 HKT/SGT |
|
Eisai's "URECE(R)" (Dotinurad) Approved in China for Gout Patients with Hyperuricemia |
| Dec 5, 2024 10:22 HKT/SGT |
|
"LEQEMBI" (Lecanemab) Approved for the Treatment of Early Alzheimer's Disease in Mexico |
| Nov 28, 2024 15:26 HKT/SGT |
|
LEQEMBI (Lecanemab) for the Treatment of Alzheimer's Disease Launched in South Korea |
| Nov 26, 2024 14:50 HKT/SGT |
|
Eisai Signs Research Collaboration Agreement with The National Center of Neurology and Psychiatry to Initiate Apolipoprotein E Genetic Testing in the "AD-DMT Registry" in Japan |
| Nov 20, 2024 10:51 HKT/SGT |
|
Rozebalamin for Injection 25mg (Mecobalamin) for Amyotrophic Lateral Sclerosis Launched in Japan |
| Nov 20, 2024 09:24 HKT/SGT |
|
Anticancer Agent "TASFYGO Tablets 35mg" (Tasurgratinib Succinate) Launches in Japan for Biliary Tract Cancer with FGFR2 Gene Fusion or Rearrangements |
| Nov 15, 2024 16:33 HKT/SGT |
|
Nationwide TV Commercial Launched in Japan to Raise Awareness About MCI (Mild Cognitive Impairment) |
| Nov 15, 2024 13:31 HKT/SGT |
|
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease |
| Nov 5, 2024 10:35 HKT/SGT |
|
Eisai's Corporate Venture Capital Subsidiary, Eisai Innovation, Inc., Selected for AMED's 'Strengthening Program for Pharmaceutical Startup Ecosystem" |
| More news >> |
 |
|
|
|
