Amgen announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase 3 trial (20120215) showed that the primary endpoint of event-free survival was met.

Novartis’s new gene-modifying cancer therapy’s $475,000-per-patient sticker price has drawn fire from advocate groups calling for cheaper drugs, but analysts said the Swiss drugmaker could initially struggle to break even.

Novartis’ anticipated leukemia treatment Kymriah is the first gene therapy to receive U.S. marketing clearance.

A U.S. Food and Drug Administration advisory panel unanimously recommended approval of Novartis AG’s CAR-T therapeutic, CTL019 (tisagenlecleucel), for B-cell acute lymphoblastic leukemia.