FDA approves Amgen’s sBLA for BLINCYTO

Amgen has announced that the U.S. Food and Drug Administration (FDA) recently approved its BLINCYTO (blinatumomab) supplemental Biologics License Application (sBLA) for the inclusion of new information that supports the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients.

The decision by the FDA was done under accelerated approval with continued approval dependent on consequent trials verifying the clinical benefit of BLINCYTO.

The results from the Phase 1/2 ‘205 clinical trial was the basis for the approval by the FDA. The single-arm trial was open-label and conducted over multiple centers, assessing the safety and efficiency of BLINCYTO when used to treat relapsed or refractory B-cell precursor ALL in pediatric patients.