FDA approves the bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy for B-cell precursor acute lymphoblastic leukemia (ALL).

Amgen’s drug BLINCYTO® (blinatumomab) is the first-and-only approved bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy. It was approved in December 2014 for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. It received subsequent FDA approvals for the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia in September 2016 and for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children in July 2017 (converting its accelerated approval to full approval). 

In March 2018, Amgen’s supplement Biologics License Application for use of BLINCYTO to treat B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission in adults and children was approved (https://www.thepharmaletter.com/article/fda-approves-new-indication-for-leukemia-drug-blincyto) by FDA. The approval is for patients minimal residual disease (MRD) is greater than or equal to 0.1 percent. The sBLA was approved under accelerated approval, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.

BLINCYTO is now the first-and-only therapy to be FDA-approved for MRD. “The detection of remaining cancer cells after a complete remission is the strongest prognostic factor for relapse in patients with ALL. It’s critical to test for and know your patients’ MRD status, because we know that treating to MRD-negativity will help to obtain better possible clinical outcomes for patients,” explained Associate Professor Elias Jabbour of the University of Texas MD Anderson Cancer Center, Houston, Department of Leukemia. 

The safety results for MRD-positive patients were consistent with the known safety profile of BLINCYTO in relapsed or refractory B-cell precursor ALL. The drug will be issued with a boxed warning for cytokine release syndrome and neurologic toxicities. BLINCYTO is also under a risk evaluation and mitigation strategy (REMS) program in the U.S.