Amgen's Blincyto Approved for B-Cell ALL

Blincyto, which was considered a promising immunotherapy with a novel mechanism of action, was approved 5 months prior to its PDUFA date.

The FDA today announced the approval of the anti-CD19 molecule, Blincyto (blnatumomab), in the treatment of patients with a rare form of acute lymphoblastic leukemia, Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL). This new immunotherapy boosts T-cells of the body's immune system to fight the leukemia. Intended for use in relapsed or refractory patients, Blincyto was developed by the biotechnology company Amgen.

“Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising for patients with leukemia,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Recognizing the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent.”

Preliminary results with the drug were deemed promising by the FDA, which resulted in it being granted a breakthrough therapy designation, a priority review, and orphan product designation. Safety and efficacy studies of Blincyto showed that 32% of 185 adults were in complete remission for 6.7 months. The approval, which includes a Risk Evaluation and Mitigation Strategy for Blincyto, comes 5 months ahead of the PDUFA date.

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FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia