Eye­ing a fast pitch for quick OK in race with blue­bird, J&J/Leg­end team en­joys a reg­u­la­to­ry em­brace for their ri­val BC­MA CAR-T

J&J and its part­ners at Leg­end just picked up brag­ging rights to the EMA’s VIP pro­gram for their made-in-Chi­na BC­MA CAR-T, of­fer­ing some much-need­ed reg­u­la­to­ry love af­ter a few in­flu­en­tial an­a­lysts turned a cold shoul­der to it last year.

The de­ci­sion to be­stow their Prime des­ig­na­tion on JNJ-68284528 is based on LEG­END-2 da­ta for mul­ti­ple myelo­ma we saw at ASH last year — which is what un­der­whelmed some of the an­a­lysts — as well as some da­ta the in­dus­try has yet to see from a Phase I/II study dubbed CAR­TI­TUDE-1. And J&J plans to take max­i­mum ad­van­tage of the open doors in Am­s­ter­dam as it hus­tles up a fast pitch for a quick ap­proval.

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