Amgen submits sBLA to FDA for BLINCYTO

Amgen announced earlier this week that it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental Biologics License Application (sBLA) for BLINCYTO (blinatumomab) that will include new information to support the treatment of pediatric and adolescent patients who have been diagnosed with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

BLINCYTO is the first and only current bispecific CD19-directed CD3 T cell engager (BiTE) treatment approved by the FDA to combat the rapidly progressing blood and bone marrow cancer known as Ph- relapsed or refractory B-cell precursor ALL.

ALL remains the most common form of cancer among children, and even though 95 percent of children who contract the disease are healed with fist-line treatments, about 650 will relapse this year in the United States. When patients relapse, the survival rate is less than 10 percent. New strategies that can improve response rates are needed to combat relapsed ALL.

The sBLA submitted for BLINCYTO by Amgen presents new data collected from the Phase 1/2 ‘205 single-arm trial. This trial found that BLINCYTO helped a "clinically meaningful number" of pediatric patients with Ph- relapsed or refractory B-cell precursor ALL achieve complete remission.