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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