publication date: Feb. 17, 2017

Drugs and Targets Amgen submits Supplemental Biologics License Application for Blincyto

Amgen announced on Tuesday the submission of a supplemental Biologics License Application to the FDA for Blincyto, or blinatumomab, to include overall survival data from the phase 3 TOWER study, supporting the conversion of Blincyto’s accelerated approval to full approval.

The Biologics License Application, or sBLA, also includes new data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The application aims to broaden Blincyto’s indication for the treatment of patients with relapsed or refractory B-cell precursor ALL. Blincyto was previously granted breakthrough therapy designation and accelerated approval in December 2014. It is also the first FDA-approved bispecific CD19-directed CD3 T cell engager, or BiTE, antibody, and the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.

Results from the TOWER study, investigating the efficacy of Blincyto versus standard of care chemotherapy in adult patients with Ph- relapsed or refractory B-cell precursor ALL, were presented during the Presidential Symposium at the 21st Congress of the European Hematology Association.

ALL is a rare and rapidly progressing cancer of the blood and bone marrow. In adult patients with relapsed or refractory ALL, median OS is just three to five … Continue reading Amgen submits Supplemental Biologics License Application for Blincyto

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