Interview: Measured Launch, Long Future For Gilead CAR-T In Europe

Gilead Sciences Inc. and Novartis AG are poised to simultaneously launch Europe's first CAR-T therapies within the next couple of months following the expected approval from the European Commission of Gilead's Yescarta (axicabtagene ciloleucel) and Novartis' Kymriah (tisagenlecleucel). Both therapies received a positive opinion from the European Medicines Agency's drug evaluation committee, the CHMP, on June 29, paving the way for approval in early September. Both are recommended for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), while Yescarta is also recommended for primary mediastinal B-cell lymphoma and Kymriah for B-cell acute lymphoblastic leukemia.

While Yescarta and Kymriah have both been launched in the US already, the timing and the indications were different. Kymriah won approval first for the small indication of pediatric acute lymphocytic leukemia in August 2017 while Yescarta was approved in October for adults with relapsed or refractory large B-cell lymphoma. Kymriah won its second indication, for adults with r/r large B-cell lymphoma, in May 2018