Dhakal Reflects on the FDA Approval of Cilta-Cel for Earlier Lines of RRMM

In this episode of Targeted Talks, ​​Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses the recent FDA approval of ciltacabtagene autoleucel (cilta-cel; Carvytki) for the treatment of patients with relapsed/refractory multiple myeloma that has been treated with at least 1 prior line of therapy, including a proteasome inhibitor and immunomodulatory agent and is refractory to lenalidomide. (Revlimid).

Cilta-cel is a chimeric antigen receptor (CAR) T-cell therapy that was previously granted approval by the FDA in February 2022 for patients with relapsed/refractory multiple myeloma who had received at least 4 prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.3

On April 5, 2024, the FDA approved cilta-cel for patients with multiple myeloma who have received at least 1 prior line of therapy and are refractory to lenalidomide based on findings from the phase 3 CARTITUDE-4 study (NCT04181827).1 The study showed that the median progression-free survival (PFS) at a median follow-up of 15.9 months (range, 0.1-27.3) was not reached in the cilta-cel arm compared with 11.8 months in the standard-of-care (SOC) arm (HR, 0.26; 95% CI, 0.18-0.38; P <.001). At 12 months, the PFS rates were 75.9% (95% CI, 69.4%-81.1%) vs 48.6% (95% CI, 41.5%-55.3%) in the cilta-cel vs SOC arms, respectively.2

“I think the approval of this in that indication is really kind of an important milestone, and really helps in improving the outcomes for these patients,” says Dhakal.

REFERENCES:

1. Carvykti is the first and only BCMA-targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. News release. Johnson & Johnson. April 5, 2024. Accessed June 12, 2024. https://tinyurl.com/43znj9t2

2. San-Miguel J, Dhakal B, Yong K, et al. Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med. 2023;389(4):335-347. doi:10.1056/NEJMoa2303379