CAR-T療法であるtisagenlecleucel(Kymriah®)、欧州で小児・若年(25歳まで)の再発・難治性B細胞性急性リンパ性白血病および再発・難治性びまん性大細胞型B細胞性リンパ腫を対象に承認【スイス・NOVARTIS】

Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)

・The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r pediatric B-cell ALL and r/r DLBCL
・Novartis is the only company with an approved CAR-T cell therapy for pediatric r/r B-cell ALL and the first to receive approval in two distinct indications, both in the EU and the US
・Novartis continues its strategy to expand manufacturing facilities with agreements with external collaborators, such as CELLforCURE in France

 

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