When Bristol Myers Squibb and bluebird bio scored an FDA nod for their multiple myeloma CAR-T drug Abecma in March, industry watchers knew a competitor from Johnson & Johnson and Legend Biotech wasn’t too far behind. Now, that rival is in the FDA’s fast lane.
J&J and Legend’s ciltacabtagene autoleucel, otherwise known as cilta-cel, scored an FDA priority review, setting up an FDA decision by Nov. 29. The candidate, a BCMA-directed CAR-T therapy, is up for approval in patients with relapsed or refractory multiple myeloma.
If approved, the drug would challenge BMS and bluebird bio’s new CAR-T Abecma, which won its March green light after a previous rejection.