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Kite On Course For FDA Filing On Positive CAR-T Durability Data

 
• By Sukaina Virji

Kite Pharma is looking stronger than ever in the race to get a CAR-T product onto the market following positive topline results from a primary six-month analysis for KTE-C19 in aggressive NHL (ZUMA-1).

Data from the pivotal Phase I/II ZUMA-1 trial of Kite Pharma Inc.'s CAR-T cell therapy KTE-C19 in patients with aggressive non-Hodgkin’s Lymphoma will support a rolling BLA submission due shortly and a regulatory filing in Europe later this year.

The latest data showed that responses achieved in patients treated with KTE-C19 at the three-month mark remained durable at six...

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