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Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma

Eighteen-month follow-up data from pivotal CARTITUDE-1 study, including progression-free-survival data, to be presented at ASCO and EHA Annual Meetings Findings from the Phase 2 CARTITUDE-2 study ....

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Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma

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Application based on positive Phase 1b/2 data from the CARTITUDE-1 study and follows confirmation of accelerated assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency
The Janssen Pharmaceutical Companies of Johnson Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma.
The application is supported by positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel. ....

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