publication date: Jul. 14, 2017

Drugs and Targets

FDA converts accelerated approval of Amgen’s Blincyto to full approval in ALL

FDA has approved the supplemental Biologics License Application for Blincyto (blinatumomab) to include overall survival data from the phase III TOWER study.

The approval converts Blincyto’s accelerated approval to a full approval. The sBLA approval also included data from the phase II ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.

“For researchers and physicians, overall survival is the primary goal of treatment and the gold standard of outcomes, demonstrating a clear value to patients,” said Anthony Stein, study investigator and co-director of the Gehr Family Center for Leukemia Research, City of Hope. “Data from the TOWER study support the use of this single agent bispecific T cell engager immunotherapy, the first to demonstrate superior overall survival in patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL, offering a much needed alternative with significantly improved outcomes over standard of care chemotherapy.”

BLINCYTO, the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL, was previously granted breakthrough therapy designation and accelerated approval.

It is also the first-and-only FDA-approved CD19-directed CD3 bispecific T cell engager (BiTE) immunotherapy, and the first bispecific antibody construct from Amgen’s BiTE platform.

“Relapsed or refractory ALL is often a lethal disease, with a median overall survival of just four months on standard of care chemotherapy,” said Bijal Shah, medical oncologist, Moffitt Cancer Center. “As a physician, my goal is to identify treatments that improve response … Continue reading FDA converts accelerated approval of Amgen’s Blincyto to full approval in ALL

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