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Conditional approval granted to cilta-cel by the EC

May 27, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory MM

On May 26, 2022, the European Commission (EC) granted a conditional marketing authorization to ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed/refractory multiple myeloma (MM).1 This decision is made 2 months after the favorable opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

Cilta-cel’s approval is based on the results of the CARTITUDE-1 trial and depends on the provision of comprehensive and long-term data at a later stage. The current indication is for treating adult patients with relapsed/refractory MM who have received ≥3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.1

Updated data from both the CARTITUDE-1 and CARTITUDE-2 trials are expected to be presented at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA)2022 Hybrid Congress.2,3

Review here the ongoing and planned clinical trials investigating cilta-cel for the treatment of patients with MM.

  1.  European Commission grants conditional approval of CARVYKTI® (ciltacabtagene autoleucel), Janssen’s first cell therapy, for the treatment of patients with relapsed and refractory multiple myeloma. https://www.janssen.com/european-commission-grants-conditional-approval-carvykti-ciltacabtagene-autoleucel-janssens-first. Published May 26, 2022. Accessed May 26, 2022.
  2. American Society of Clinical Oncology (ASCO). 2022 ASCO Annual Meeting Scheduled Sessions. https://meetings.asco.org/meetings/2022-asco-annual-meeting/288/program-guide/scheduled-sessions. Published Apr 27, 2022. Accessed May 26, 2022.
  3. European Hematology Association (EHA). EHA2022 Hybrid Congress Program. https://ehaweb.org/congress/eha2022-hybrid/program/program-by-day/. Published May 12, 2022. Accessed May 26, 2022.

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