FDA Approves Amgen's Supplemental Biologics License Application For Blincyto

(RTTNews) - Amgen (AMGN) Thursday said the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for Blincyto for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia.

This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Blincyto is the first-and-only approved bispecific CD19-directed CD3 T cell engager immunotherapy and now also the first-and-only therapy to be FDA-approved for MRD.

"Until today, no therapy has been satisfactory in eradicating MRD or approved specifically to treat this high-risk patient population," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "This approval not only supports the use of BLINCYTO earlier in the ALL treatment continuum, but represents a paradigm shift in the management of ALL."

MRD refers to the presence of cancer cells that remain detectable, despite a patient's having achieved complete remission by conventional assessment. MRD is only measurable through the use of highly sensitive testing methods that detect cancer cells in the bone marrow with a sensitivity of at least one cancer cell in 10,000 cells.