Amgen Submits BLA For Blinatumomab - Quick Facts

(RTTNews) - Amgen (AMGN) announced the submission of a Biologics License Application (BLA) to the U.S. FDA seeking approval for its investigational bispecific T cell engager antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia, or ALL, a cancer of the blood and bone marrow. The company said the submission includes data from a Phase 2 trial of adult patients with Ph-relapsed/refractory B-precursor ALL treated with blinatumomab, which successfully met its primary endpoint.

Blinatumomab is an investigational BiTE antibody construct 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. Amgen has received orphan drug designation from the FDA for the treatment of ALL, chronic lymphocytic leukemia, hairy cell leukemia, prolymphocytic leukemia and indolent B-cell lymphoma and from the European Medicines Agency for the treatment of indolent B-cell lymphoma, ALL, CLL and mantle cell leukemia.