Gilead­'s Kite keeps adding to CAR-T Yescar­ta's bag of tricks with FDA ap­proval in fol­lic­u­lar lym­phoma — a first

Sev­er­al months af­ter cre­at­ing the first com­mer­cial CAR-T port­fo­lio with the FDA’s nod for Tecar­tus, Gilead’s Kite has racked up a sought-af­ter new in­di­ca­tion for its flag­ship cell ther­a­py Yescar­ta.

The FDA on Fri­day grant­ed Yescar­ta — al­so known as axi­cab­ta­gene ciloleu­cel — an ac­cel­er­at­ed ap­proval as a third-line ther­a­py for adults with re­lapsed or re­frac­to­ry fol­lic­u­lar lym­phoma (FL).

The de­ci­sion was based on the Phase II ZU­MA-5 tri­al, an open-la­bel study in which 146  in­do­lent non-Hodgkin’s lym­phoma pa­tients re­ceived a sin­gle in­fu­sion of Yescar­ta af­ter two or more lines of treat­ment — in­clud­ing 124 with FL and 22 with mar­gin­al zone lym­phoma.

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