On February 14, Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the supplemental biologics license application (sBLA) for blinatumomab (Blincyto) for the treatment of patients with minimal residual disease (MRD)–positive B-cell precursor acute lymphoblastic leukemia (ALL) at a meeting on March 7, 2018.
“After achieving remission, the presence of MRD is the strongest prognostic factor for relapse in acute lymphoblastic leukemia. However, today up to half of patients remain MRD-positive after induction treatments and receive limited clinical benefit from treatments like chemotherapy or stem cell transplantation as a result of failure to identify and treat this residual disease,” said David M. Reese, MD, Senior Vice President of Translational Sciences and Oncology at Amgen. “Currently, there are no approved therapies for patients with MRD-positive ALL, representing a significant unmet need. This sBLA for blinatumomab is the first application to ever be submitted for an MRD-positive indication, and we look forward to discussing the supporting data with members of the Committee.”
The Committee will review results from clinical studies in support of this potential new indication, including results from the phase II BLAST study evaluating patients with B-cell precursor ALL and persistent or recurrent MRD after at least three cycles of intensive chemotherapy.
Blinatumomab is the first-and-only approved bispecific CD19-directed CD3 T-cell engager (BiTE) immunotherapy. It is also the first bispecific antibody construct from Amgen's BiTE platform, which helps the body's immune system target cancer cells and represents an entirely new area of oncology research.
The sBLA for Blincyto was accepted by the FDA for priority review, and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2018, has been set.
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