FDA Approval Insights: Cilta-Cel in R/R Myeloma After at Least 1 Prior Line of Therapy

Welcome to OncLive On Air^®! I’m your host today, Chris Ryan.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Janssen, we had the pleasure of speaking with Saad Z. Usmani, MD, MBA, FACP, FASCO, about the FDA approval of ciltacabtagene autoleucel (Carvykti; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide (Revlimid). Dr Usmani is a hematologist-oncologist and chief of the Myeloma Service at Memorial Sloan Kettering Cancer Center in New York, New York.

On April 5, 2024, the regulatory agency approved the new indication for cilta-cel based on data from the phase 3 CARTITUDE-4 study (NCT04181827), which showed that at a median follow-up of 15.9 months (range, 0.1-27.3), patients treated with the CAR T-cell therapy (n = 208) experienced a median progression-free survival that was not yet reached compared with 11.8 months (95% CI, 9.7-13.8) for patients given standard-of-care combination regimens (n = 211; HR, 0.26; 95% CI, 0.18-0.38; P <.001).

In our exclusive interview, Dr Usmani detailed the significance of the approval of cilta-cel for the treatment of select patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy; expanded on the efficacy and safety data derived from CARTITUDE-4; and explained where the CAR T-cell therapy now fits in the multiple myeloma treatment paradigm.

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That’s all we have for today! Thank you for listening to this episode of OncLive On Air, sponsored by Janssen. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

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