Amgen obtains FDA Priority Review for BLINCYTO (blinatumomab)

U.S. FDA News

Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab).  BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.  With the sBLA, Amgen seeks to add an indication for Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia.  The sBLA is based on results from the TOWER study, a Phase 3, randomized, active-controlled, open-label study investigating the efficacy of BLINCYTO versus SOC chemotherapy in 405 adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

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