Gilead/Kite’s Tecartus Moves Into Leukemia With Second US Indication

With the second US Food and Drug Administration approval for its CAR-T therapy Tecartus and the company’s first approval in a leukemia setting, Kite Pharma, Inc. CEO Christi Shaw said the Gilead Sciences, Inc. cell therapy subsidiary is ready to look ahead to second priorities now that the initial priority of a full-fledged cell therapy portfolio is growing more substantial.

The FDA granted Tecartus (brexucabtagene autoleucel) approval for second-line-plus treatment of adults with relapsed/refractory acute lymphoblastic leukemia on 1 October. This adds to the CD19-targeted cell therapy’s initial US indication of mantle cell lymphoma, obtained in July 2020. (Also see "Gilead/Kite Gain Second CAR-T Approval With Tecartus, Price On Par With Their First" - Scrip, 27 July, 2020.) Gilead already had Yescarta (axibabtagene ciloleucel) on the market, which was approved for third line or later relapsed/refractory large B-cell lymphoma in 2017, putting it in direct competition with Novartis AG’s Kymriah (tisagenlecleucel), the first approved chimeric antigen receptor T-cell (CAR-T) therapy