ARTICLE | Regulation
CHMP’s October recommendations
October 17, 2020 1:50 AM UTC
EMA’s CHMP has backed autologous cells therapies Tecartus, from Gilead, and Lebmeldy, from Orchard, in its October set of opinions.
The agency recommended conditional marketing approval for Tecartus brexucabtagene autoleucel from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD) to treat mantle cell lymphoma. FDA approved the drug in July as the first CD19-directed CAR T cell therapy for the indication...