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J&J, Legend Biotech’s multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS’ Abecma

May 28, 2021


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.

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