Janssen’s First Cell Therapy Approved by FDA for Patients with Multiple Myeloma

With support from promising clinical trial results, Janssen’s ciltacabtagene autoleucel (cilta-cel; Carvykti) has been approved by the US Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) after 4 or more prior lines of therapy, including a proateasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Cilta-cel is Janssen’s first cell therapy. The chimeric antigen receptor T-cell (CAR-T) therapy features 2 B-cell maturation antigen (BCMA)-targeting single domain antibodies.

The CARTITUDE-1 study examined patients with RRMM who had previously received between 3-18 prior treatment regimens (median of 6), and had previously received a proateasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

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