FDA gives full approval to Amgen leukemia drug Blincyto
Amgen’s leukemia drug Blincyto received full approval from the U.S. Food and Drug Administration on July 11 to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children.
The biotech giant, headquartered in Thousand Oaks, had previously announced that the drug had been fast-tracked for priority review. The full approval includes data on overall survival rates from a Phase 3 study of 405 difficult-to-treat adults in varying stages of relapse, published in the New England Journal of Medicine.
“For researchers and physicians, overall survival is the primary goal of treatment and the gold standard of outcomes, demonstrating a clear value to patients,” Anthony Stein, study investigator and co-director of the Gehr Family Center for Leukemia Research, said in a news release, calling it a “much-needed alternative with significantly improved outcomes over standard of care chemotherapy.”
Adults with relapsed or refractory acute lymphoblastic leukemia — a rare and rapidly progressing cancer of the blood and bone marrow — typically have a median overall survival rate of three to five months, according to the news release. With Blincyto, the study showed that median survival rates nearly doubled to 7.7 months.
The drug is the first product from Amgen’s bispecific T-cell engager, or BiTE, platform.
“This approval supports the use of Blincyto in a broader spectrum of patients, including those with few options to date, such as Philadelphia chromosome-positive patients, and reinforces the potential of the BiTE platform as a novel approach to immuno-oncology,” said Sean Harper, executive vice president of research and development at Amgen.
The approval includes warnings in its prescription information and the drug is under an FDA risk evaluation and mitigation strategy program in the U.S.
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