EU CAR-T Race Tightens After Yescarta Reverts To Standard Review

 
• By Maureen Kenny
  
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Kite and Novartis are vying to be the first company to have a CAR-T therapy approved in the EU. Both companies are hoping to be able to treat patients with r/r DLBCL.

Kart crossing the finish line
The CAR-T race in the EU could have a close finish • Source: Shutterstock

Kite Pharma’s novel CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), is taking longer to get through the EU review process than the US company had initially hoped. The product, which is under evaluation for the treatment of several aggressive forms of non-Hodgkin lymphoma (NHL), was initially being reviewed under the European Medicines Agency’s accelerated assessment mechanism but recently reverted to a standard review timetable.

Kite Pharma Inc. said EU approval of its cancer gene therapy was now expected in “mid-2018”; previously it had...

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