European regulators cleared Amgen’s candidate for a rare form of leukemia nearly three years after its conditional approval.
The drug, Blincyto, is indicated for treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia. EU authorities granted it conditional approval in November 2015.
Regulators based the full authorization on a Phase 3 clinical trial. In the trial, Blincyto showed a superior improvement over standard of care chemotherapy.