First CAR T-Cell Therapies OK'd In EU: Novartis's Kymriah And Kite's Yescarta

 
• By Ian Schofield and Neena Brizmohun
  
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The European Medicines Agency's drug evaluation committee, the CHMP, has recommended nine products for marketing authorization in the EU, including the first two CAR T-cell therapies, Novartis's Kymriah and Kite Pharma's Yescarta, as well as four other orphan drugs.

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The CHMP has recommended nine products for marketing authorization in the EU

It's a double first for two pioneering advanced therapy products for oncology indications in Europe: Novartis AG's Kymriah (tisagenlecleucel) and Gilead subsidiary Kite Pharma Inc.'s Yescarta (axicabtagene ciloleucel). Not only are they the first CAR T-cell therapy products to get the OK from the European Medicines Agency's drug evaluation committee, the CHMP, but they are also the first medicines supported through the EMA’s priority medicines (PRIME) scheme to receive a positive opinion from the committee.

Seven other products also received a positive opinion from the CHMP following its latest plenary meeting, which took place on...

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