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

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 specifically said it was likely in the first half of the year. The company said the EMA needed time to understand the data for the marketing authorization application (MAA) for the product, which is being evaluated in the EU for certain B cell lymphomas including relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), the most common type of NHL in adults. The Gilead subsidiary filed the European MAA at the end of July 2017