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FDA approves Blincyto for PH-negative precursor B-cell ALL

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The FDA today announced the accelerated approval of blinatumomab for patients with Philadelphia chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukemia.

Blinatumomab (Blincyto, Amgen) — a bispecific CD19-directed CD3 T-cell engager — is the first FDA-approved immunotherapy that activates the patient’s T cells against their leukemia cells.

“Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising for patients with leukemia,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

Richard Pazdur

The approval is based in part on results of a study that included 185 adults with Philadelphia chromosome-negative (PH-negative) relapsed or refractory precursor B-cell ALL. Patients received IV infusions of blinatumomab for at least 4 weeks.

Overall, 32% (95% CI, 26-40) of patients achieved complete remission, and the median response duration was 6.7 months (range, 0.46-16.5). Thirty-one percent of patients (95% CI, 25-39) achieved a complete remission with or without complete hematological recovery with a minimal residual disease reduction to <10^-4.

The most common adverse events associated with blinatumomab were pyrexia (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%). Fifty percent of patients experienced a neurologic toxicity, which was a common reason for treatment interruption.

The risks for cytokine release syndrome — which occurred in 11% of trial participants —  encephalopathy and other nervous system side effects will be listed on a boxed warning.

The FDA previously granted breakthrough therapy designation, priority review and orphan product designation to blinatumomab.