Idecabtagene Vicleucel Approved by FDA in R/R Multiple Myeloma


The FDA has approved idecabtagene vicleucel for patients with relapsed/refractory multiple myeloma who have received 2 prior lines of therapy.

Image of "FDA Approved" in blue and green.

FDA approves idecabtagene vicleucel in relapsed/refractory multiple myeloma.

The FDA granted an approval to idecabtagene vicleucel (ide-cel; Abecma) for the treatment of adults with relapsed or refractory multiple myeloma who were treated with 2 or more previous lines of therapy, which include an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody (triple-class exposed).

Idecabtagene vicleucel was previously approved by the FDA in March 2021. The CAR-T cell therapy was approved to treat patients with relapsed or refractory multiple myeloma after receiving 4 or more lines of prior therapy, including the three classes of main treatments.

This approval was based on findings from the phase 3 KarMMa-3 trial (NCT03651128). In this open-label, global, randomized, controlled trial, researchers evaluated 386 patients to receive either idecabtagene vicleucel (n= 254) or standard regimen combinations (n= 132), including daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone. The combinations were chosen based on investigator’s choice and the patients’ most recent treatment regimen.

At the primary progression-free survival (PFS) analysis at an estimated median duration follow-up of 15.9 months, the primary end point of PFS was more than tripled in patients receiving idecabtagene vicleucel, compared with standard regimens. The median PFS was 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; 95% CI: 0.38-0.64; p<0.0001).

Patients receiving idecabtagene vicleucel reflected a 51% reduction for the risk of disease progression or death. The treatment also demonstrated a significant improvement in overall response rates (p<0.0001), of which 71% of patients who received idecabtagene vicleucel achieved a response, and 39% achieved a complete or stringent complete response.

Less than half of patients (42%) who received standard regimen combinations achieved a response, of which 5% experienced a complete response or stringent complete response. The median duration of response (DOR) was 14.8 months (95% CI: 12.0-18.6) in patients who received idecabtagene vicleucel. Patients who had a complete response or better had a median DOR of 20 months (95% CI: 15.8-24.3).

“Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey,” Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb, stated in the news release. “This approval underpins our commitment to addressing the unmet needs of more patients living with multiple myeloma by improving upon the current treatment paradigm, and we remain steadfast in our pursuit of innovation and advancing cell therapy research to deliver potentially transformative therapies.”

The most common adverse events (AEs) were low-grade cytokine release syndrome (CRS) and neurotoxicity. In patients who received idecabtagene vicleucel, any grade CRS occurred in 89% of patients from the KarMMA and KarMMA-3 trials. Grade 3 or lower CRS occurred in 7% of patients, and grade 5 CRS was reported in 3 cases. The median onset time for CRS was 1 day (range: 1-27 days), and the median duration was 5 days (range: 1-63 days).

Any grade neurotoxicity occurred in 40% of patients who received idecabtagene vicleucel in both the KarMMA and KarMMA-3 trials. Grade 3 neurotoxicity occurred in 4% of patients, with 2 cases of grade 4 neurotoxicities. There was 1 case of grade 5 neurotoxicity in this patient population. For neurotoxicity, the median onset time was 2 days (range: 1-148 days), and the median duration was 8 days (range: 1-720 days).

“The results of the KarMMa-3 study are remarkable, especially given the historic outcomes with standard regimens for these patients with relapsed or refractory disease,” Al-Ola A. Abdallah, M.D., University of Kansas, Clinical Associate Professor, Clinical Director, Hematologic Malignancies and Cellular Therapeutics and chair of U.S. Myeloma Innovations Research Collaborative, said in the statement. “With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach.”


U.S. FDA Approves Bristol Myers Squibb and 2seventy bio’s Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy. News release. Bristol Myers Squibb and 2seventy bio. April 5, 2024. Accessed April 5, 2024.

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