'We are ready to go': FDA OKs J&J and Leg­end's BC­MA CAR-T, set­ting stage for show­down with Bris­tol My­ers

Move over, Bris­tol My­ers Squibb. Af­ter de­lay­ing their de­ci­sion by three months to re­view new in­for­ma­tion, the FDA has cleared John­son & John­son and Leg­end’s BC­MA CAR-T ri­val cil­ta-cel, set­ting the stage for a show­down in mul­ti­ple myelo­ma.

Cil­ta-cel — which will be sold as Carvyk­ti — marks the in­dus­try’s sec­ond BC­MA CAR-T ap­proval, com­ing about a year be­hind BMS and blue­bird’s Abec­ma (which is now in 2sev­en­ty’s pipeline, af­ter blue­bird’s split in two). But even though the lat­ter drug was the first to cross the fin­ish line, Leg­end and Janssen say some long-term da­ta sug­gest they have the up­per hand here, and they’re ready to start rolling out cil­ta-cel “im­me­di­ate­ly.”

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