Immuno-oncology Innovation From Amgen Set for Priority Review

The new BiTE antibody technology developed by the company can simultaneously engage 2 different targets, which can help recruit T-cells to malignant cells, and will be evaluated in ALL patients.

Amgen (NASDAQ: AMGN) today announced that the FDA has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE®) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.1 As part of the acceptance, the FDA granted blinatumomab priority review with a Prescription Drug User Fee Act (PDUFA) action date of May 19, 2015.

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 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.

Read Amgen's full press release: