FDA approves Kite CAR T therapy Yescarta

By The Science Advisory Board staff writers

April 7, 2022 -- The U.S. Food and Drug Administration has approved axicabtagene ciloleuce (Yescarta), a CAR T-cell therapy manufactured by Kite, a Gilead company. Kite focuses on cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

In patients with LBCL, Yescarta demonstrated significant improvement in event-free survival. The Zuma-7 trial demonstrated that patients on Yescarta were 2.5 times more likely to be alive at two years without cancer progression or need for additional cancer treatment.

The company said that it is the first LBCL treatment to improve upon the standard of care in nearly 30 years and the first CAR T-cell therapy to receive a National Comprehensive Cancer Network treatment guideline category 1 recommendation.

Kite submits BLA for CAR T in non-Hodgkin lymphomas
Kite, a Gilead company, has submitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration for axicabtagene ciloleucel...
Kite to manufacture CAR T-cell therapy in Europe
Gilead subsidiary Kite has received approval from the European Medicine Agency for end-to-end manufacturing of individualized cell therapies at its European...

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