CAR-T therapy recommended for melanoma after first relapse

CAR-T therapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM).

The recommended indication for cilta-cel is for the treatment of adult patients with RRMM, who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.

Cilta-cel is the first chimeric antigen receptor T-cell (CAR-T) therapy to receive a positive CHMP opinion for the treatment of this patient population, as early as after first relapse.

Cilta-cel is a CAR-T therapy directed against B-cell maturation antigen (BCMA), a protein that is highly expressed on myeloma cells.

“Early resistance to standard treatments is becoming more common in patients with lenalidomide-refractory multiple myeloma, highlighting a need for new options earlier in the course of treatment,” said Edmond Chan, Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited, a Johnson & Johnson Company. “Today’s recommendation from the CHMP recognises the potential of cilta-cel to significantly improve outcomes for eligible patients with relapsed and refractory multiple myeloma, as early as after first relapse.”

The CHMP recommendation for cilta-cel is supported by data from the CARTITUDE-4 study, which evaluated the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with RRMM who received one to three prior lines of therapy.

In November 2023, the US Food and Drug Administration (FDA) announced it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies like Carvykti, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients.

Diana Spencer, Senior Digital Content Editor, DDW

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