FDAnews Drug Daily Bulletin

FDA Grants Full Approval to Amgen’s Blincyto in ALL

July 19, 2017

The FDA converted its accelerated approval of Amgen’s Blincyto to a full approval, following the submission of data from Phase II and III studies, supporting the treatment of adults and children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Blincyto was previously granted a Breakthrough Therapy designation, and is the first-and-only FDA-approved CD19-directed CD3 bispecific T cell engager immunotherapy, according to the company, and the first bispecific antibody construct from Amgen's BiTE platform.

The Phase III trial found that Blincyto nearly doubled median overall survival over standard-of-care chemotherapy, at 7.7 months compared to 4.0 months. Blincyto includes a boxed warning for cytokine release syndrome and neurologic toxicities, and is currently under a REMS program.

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