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Kite First Off The Blocks For EU CAR-T Filing

 
• By Alexandra Shimmings

Kite Pharma may have been pipped to the post to be first with a CAR-T product at the US FDA, but it has sneaked in the first EU filing courtesy of PRIME for axicabtagene ciloleucel.

Sprinter
Quick off the mark • Source: Shutterstock

Kite Pharma Inc. has staked a claim to be the first to file a chimeric antigen receptor T cell (CAR-T) therapy in the EU, having submitted a marketing authorization application for axicabtagene ciloleucel (KTE-C19) ahead of Novartis AG's leading product CTL019 (tisagenlecleucel).

The submission, based on the ZUMA-1 trial (see sidebar), is for its use as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and...

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