The U.S. FDA has approved the supplemental Biologics License Application (sBLA) for Amgen’s BLINCYTO (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD), based on additional data from two Phase 3 studies. The approval converts BLINCYTO’s accelerated approval to a full approval.

Amgen continues to advance its development program for BLINCYTO, including studies aimed at treating patients with MRD-negative B-ALL, trials designed to minimize chemotherapy, and the clinical investigation of a subcutaneous formulation, to help address remaining unmet needs for patients.

“We are pleased the FDA has granted full approval for BLINCYTO, the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy and the first to be FDA-approved for MRD in 2018,” said David M. Reese, executive vice president of Research and Development at Amgen. “Today’s full approval underscores the clinical benefit of BLINCYTO for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients.”