Amgen and Astellas’ Blincyto (blinatumomab, BiTE) Receives Japanese Marketing Approval for Treatment of R/R B-cell Acute Lymphoblastic Leukemia(ALL)

 Amgen and Astellas’ Blincyto (blinatumomab, BiTE) Receives Japanese Marketing Approval for Treatment of R/R B-cell Acute Lymphoblastic Leukemia(ALL)

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.

Click here to read full press release/ article | Ref: Amgen | Image:  Compassc Group

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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