Page 2 - Cilta Cel News Today

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Ciltacabtagene autoleucel significantly improved progression-free survival over standard-of-care pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.

A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.

Leaked data from an abstract scheduled to be presented at the 2023 EHA Hybrid Congress showed that ciltacabtagene autoleucel demonstrated a 74% reduction in the risk of disease progression or death compared with standard therapy in patients with multiple myeloma who received 1 to 3 prior lines of therapy.

Updated study results showed an overall response rate of 98% with a longer-term follow-up at a median of 18 months - News - PharmaTimes

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 e...