Amgen and Astellas' Blincyto (blinatumomab- BiTE) Receives Japanese Marketing Approval for Treatment of R/R B-cell Acute Lymphoblastic Leukemia(ALL)
Shots:
- Approval is based on P-III TOWER study administering Blincyto vs standard of care (SOC) CT in ratio (2:1) and P-1b/II Horai study administering Blincyto in Japanese adult and pediatric patients with r/r B-cell precursor ALL- assessing its safety and efficacy
- P-III TOWER(N=405) (Blincyto vs SOC CT) & P-Ib/II Horai study Results: mOS (7.7mos vs 4.0mos); showing safety and efficacy. Blincyto is developed by Amgen and Astellas Pharma joint venture Amgen Astellas BioPharma K.K. (AABP) company HQs in Tokyo
- Blincyto is novel bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy- received Breakthrough Therapy and Priority Review designations by the US FDA in 2014 for r/r ALL and is now approved in 57 countries- including the US- EU- Canada and Australia.
Ref: Amgen | Image: Amgen
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