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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