Amgen's BiTE Immunotherapy Blinatumomab Gets FDA Priority Review Status

(RTTNews) - Amgen Inc. (AMGN) said Thursday that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for the investigational bispecific T cell engager antibody construct, blinatumomab.

The BLA is for the treatment of adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia, a rapidly progressing cancer of the blood and bone marrow.

As part of the acceptance, the FDA granted blinatumomab priority review with a Prescription Drug User Fee Act action date of May 19, 2015.

According to the FDA, priority review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. A priority review designation will set a goal date for taking action on an application within six months of receipt.

A Marketing Authorization Application has also been submitted to the European Medicines Agency via the centralized procedure for approval to market blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor ALL, the company said.

The submissions include data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.