Amgen announced that the FDA has granted Breakthrough Therapy designation to blinatumomab for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
The designation was based on results from a Phase 2 trial of 189 adults with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab. Blinatumomab is the first of the BiTE antibodies and Amgen has received Orphan Drug designation from the FDA for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia, and indolent B cell lymphoma.
Blinatumomab is an investigational bispecific T cell engager (BiTE) antibody designed to direct the body’s cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas.
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