|
| Tuesday, 20 December 2016, 07:23 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
TOKYO, Dec 20, 2016 - (JCN Newswire) - Eisai Co., Ltd. announced today that the anticancer agent TREAKISYM (generic name: bendamustine hydrochloride) has been approved in Japan for an additional indication as first-line treatment for low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma (MCL). TREAKISYM is the subject of a licensing agreement concluded between Eisai and SymBio Pharmaceuticals Limited (Headquarters: Tokyo, Representative Director, President & CEO: Fuminori Yoshida, "SymBio"). Through the approval of this additional indication, TREAKISYM will now be available for adjunctive use with rituximab for untreated low-grade B-cell non-Hodgkin's lymphoma and MCL.
TREAKISYM was initially approved in Japan in October 2010 as monotherapy for relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma and MCL. Under the licensing agreement concluded between the two companies, Eisai has been marketing the product since December 2010. In August 2016, TREAKISYM was approved in Japan for an additional indication of chronic lymphocytic leukemia. For this approval of the indication for first-line low-grade B-cell non-Hodgkin's lymphoma and MCL, this indication met the development requests set by the Japanese Ministry of Health, Labour and Welfare's Council on Unapproved Drugs/Off-label Use, and SymBio submitted a supplemental New Drug Application in December 2015.
Non-Hodgkin's lymphoma is a general term that refers to lymphocytes within white blood cells that have mutated into lymphomas, except for Hodgkin's lymphoma, and represent the majority of lymphomas diagnosed in Japan. Non-Hodgkin's lymphoma is categorized by progression speed, which means lymphoma progressing annually is low-grade, monthly is mid-grade and weekly is high-grade. In addition, non-Hodgkin's lymphoma can be further categorized by which cells have become cancerous (such as B-cells) and how mature the cells are. As low-grade B-cell non-Hodgkin's lymphoma and MCL are difficult to cure completely, they are both diseases with high unmet medical needs.
Eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the value of TREAKISYM as well as its in-house developed anticancer agents including Halaven and Lenvima, seeking to contribute further to addressing the diverse needs of patients with cancer and their families.
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
Topic: Press release summary
Source: Eisai
Sectors: Healthcare & Pharm
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| Apr 1, 2025 12:15 HKT/SGT |
|
Eisai to Divest Rights for Pariet in China to Peak Pharma |
| Mar 25, 2025 16:28 HKT/SGT |
|
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards |
| Mar 25, 2025 11:21 HKT/SGT |
|
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace |
| Mar 10, 2025 19:24 HKT/SGT |
|
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time |
| Mar 5, 2025 08:09 HKT/SGT |
|
Eisai: Update on the Co-Promotion of the Oral Antifungal Agent Nailin Capsules 100mg in Japan |
| Mar 4, 2025 16:22 HKT/SGT |
|
Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer's Disease in Australia |
| Mar 3, 2025 14:41 HKT/SGT |
|
"Fatigue Recovery While You Sleep!" Eisai to Launch Designated Quasi-Drug Drink "Chocola BB Nightwell" |
| Mar 3, 2025 12:53 HKT/SGT |
|
The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease |
| Feb 28, 2025 11:31 HKT/SGT |
|
Eisai Enters into License Agreement for the Development and Distribution of Fibroblast Growth Factor (FGF) Receptor Selective Tyrosine Kinase Inhibitor Tasurgratinib in Greater China Region (Mainland China, Hong Kong, Macau, and Taiwan) with SciClone |
| Feb 20, 2025 12:29 HKT/SGT |
|
Eisai Selected for "Human Capital Leaders 2024" and "Human Capital Management Gold Quality" for Second Consecutive Year, as a Company Committed to Excellent Management and Disclosure of Human Capital Initiatives |
| More news >> |
 |
|
|
|
