EU Firsts For CAR-T & PRIME As EMA Grants Kite Accelerated Assessment

Kite Pharma claims it has filed the first EU application to market a CAR T-cell therapy, and says that being on the European Medicines Agency’s PRIME scheme was helpful when it came to getting answers to the questions it had on the application.

3d illustration of T cells or cancer cells — Kite's EU filing will be reviewed under the accelerated assessment pathway

The race to market CAR T-cell therapies in Europe appears to have moved up a gear – as has the European Medicines Agency’s PRIME (priority medicines) scheme – after Kite Pharma claimed it had submitted the first EU marketing authorization application for such a product and had been granted accelerated assessment under PRIME.

Kite’s announcement on July 31 relates to its CAR (chimeric antigen receptor) T-cell therapy axicabtagene ciloleucel for treating lymphomas. As...