Ying Huang, Legend Biotech CEO

FDA steers J&J/Leg­end CAR-T to a quick de­ci­sion as part­ners prep a loom­ing show­down with Bris­tol My­ers, blue­bird

Just days af­ter in­ves­ti­ga­tors post­ed a jaw-drop­ping set of pos­i­tive up­dat­ed da­ta for the BC­MA CAR-T cil­ta-cel — or JNJ-4528 — J&J’s part­ners at Leg­end are back with the news that the FDA is putting their ap­pli­ca­tion for the mul­ti­ple myelo­ma treat­ment in the fast lane and speed­ing it to a fall reg­u­la­to­ry de­ci­sion dead­line. And that would put them right be­hind the new­ly launched BC­MA drug Abec­ma from Bris­tol My­ers Squibb and blue­bird, wide­ly con­sid­ered now as a run­ner-up on ef­fi­ca­cy.

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