FDA fol­lows through with a ground­break­ing OK for Yescar­ta, Gilead­'s new CAR-T break­through

Just two weeks af­ter Gilead closed on its $12 bil­lion Kite buy­out, the FDA has fol­lowed through with a ground­break­ing ap­proval of Yescar­ta (axi-cel), putting its CAR-T drug neck-and-neck with No­var­tis’ pi­o­neer Kym­ri­ah as the two drugs are prepped for a launch.

In a vir­tu­al heart­beat, Gilead used its con­sid­er­able cash re­serves to reach a deal to buy out Kite and axi-cel 6 weeks ago, ac­quir­ing its new­ly ap­proved CAR-T and all the next-gen tech­nol­o­gy now in the works. The ac­qui­si­tion made Gilead an overnight leader in CAR-T. While beat­en to a his­toric first FDA ap­proval for a CAR-T by an ag­gres­sive group at No­var­tis — ini­tial­ly green-light­ed at the end of Au­gust for pe­di­atric and young adult pa­tients with a form of acute lym­phoblas­tic leukemia — Gilead is re­tain­ing most of the Kite gang and hon­ing its man­u­fac­tur­ing ef­fort, shav­ing off the time it takes to turn around these per­son­al­ized ther­a­pies.

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