FDA approves expanded indication for Amgen's Blincyto

SILVER SPRING, Md. — The Food and Drug Administration has approved Amgen’s supplemental Biologics License Application for an expanded indication for its Blincyto, the company said Thursday. 

 

The drug is now approved for treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The indication was granted under accelerated approval.