FDA Approves Blinatumomab for Acute Lymphoblastic Leukemia

December 3, 2014 6:47 PM

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The FDA has approved the bispecific T cell engager antibody blinatumomab (Blincyto) as a treatment for patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), based on promising early findings from a phase II study.

Blinatumomab, a novel immunotherapeutic agent, demonstrated a complete remission rate of 32% for a median duration of 6.7 months in patients with ALL, according to the FDA. The drug was approved under the FDA's accelerated approval program following a priority review. A decision on the drug’s applic...

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