FDA Approves Earlier Use of CAR-T Products for Myeloma

Oncology/Hematology
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Myeloma

— Carvykti and Abecma move to second- and third-line, respectively

by
Ian Ingram, Managing Editor, MedPage Today
April 8, 2024

The FDA expanded the labels of two CAR T-cell products for multiple myeloma, allowing their use in earlier lines of treatment for relapsed or refractory disease.

Ciltacabtagene autoleucel (cilta-cel; Carvykti) is now approved as a second-line therapy for patients who are refractory to lenalidomide (Revlimid), an immunomodulatory agent, and whose prior line of therapy also included a proteasome inhibitor, Johnson & Johnson announced.

Idecabtagene vicleucel (ide-cel; Abecma), meanwhile, is now approved as a third-line option for patients with triple-class-exposed disease, meaning they have been treated with an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, said Bristol Myers Squibb.

FDA’s move followed a recent meeting of the Oncologic Drugs Advisory Committee (ODAC), held due to concerns over an early increased risk for death compared with standard regimens in trials of the two B-cell maturation antigen (BCMA)-targeted agents. But ultimately, ODAC members said the benefits outweighed the risks in these earlier lines, with votes of 11-0 for cilta-cel and 8-3 for ide-cel.

Carvykti

Expanded approval of cilta-cel was based on findings from CARTITUDE-4, a phase III study that randomized 419 patients with lenalidomide-refractory myeloma to cilta-cel or one of two standard-of-care regimens: pomalidomide (Pomalyst), bortezomib (Velcade), and dexamethasone; or daratumumab (Darzalex), pomalidomide, and dexamethasone.

At a median follow-up of 15.9 months, median progression-free survival (PFS) was not reached in the cilta-cel group as compared with 11.8 months in the standard-care group (HR 0.26, 95% CI 0.18-0.38, P