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FDA Grants Priority Review to KTE-X19 in Mantle Cell Lymphoma

Gina Columbus
Published: Monday, Feb 10, 2020

Ken Takeshita, MD, global head of Clinical Development, Kite

Ken Takeshita, MD

The FDA has granted a priority review designation to a biologics license application (BLA) for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma (MCL).1 The designation is based on findings from the phase II ZUMA-2 trial, in which a single infusion of the CAR T-cell product elicited a 93% objective response rate, as assessed by an Independent Radiologic Review Committee, in patients with relapsed/refractory MCL; additionally, there was a 67% complete response (CR) rate.2
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