Amgen asserted that the Oncologic Drugs Advisory Committee of the U.S Food and Drug Administration will assess the data supporting the BLINCYTO supplemental Biologics License Application (sBLA) for the treatment of patients suffering or inflicted with minimal residual disease- positive B-cell precursor acute lymphoblastic leukemia (ALL). MRD refers to the presence of a small amount of detectible cancer cells that remain in the patient after treatment.
David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen said “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.”
BLINCYTO is the first 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.
The Committee will review results from clinical studies in support of this potential new indication, including results from the Phase 2 BLAST study evaluating patients with B-cell precursor ALL that has been accepted for review and a Prescription Drug User Fee Act (PDUFA) target action slated for March,29,2018.