Janssen seeks EU approval for first CAR-T therapy cilta-cel
Janssen seeks EU approval for first CAR-T therapy cilta-cel 4th May 2021 Johnson & Johnson’s (J&J) pharma division Janssen has filed its first CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) with the European Medicines Agency (EMA), seeking approval for the treatment of patients with relapsed/refractory multiple myeloma. The marketing authorisation application (MAA) is supported by results from Janssen’s ongoing Phase Ib/II CARTITUDE-1 study, which is investigating the safety and efficacy of cilta-cel. Results from this study were recently presented at the virtual American Societ...