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.
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