Ide-Cel Approved by European Union for MM

Idecabtagene vicleucel (ide-cel; Abecma) was approved by the European Union for the treatment of relapsed or refractory multiple myeloma (MM), according to a press release by Bristol Myers Squibb, the manufacturer of the chimeric antigen receptor (CAR)-T therapy.

Ide-cel was approved for patients who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have shown disease progression on the last therapy.

“[The] approval in the European Union marks an exciting milestone in our efforts to bring the transformative potential of cell therapies into earlier lines of treatment,” said Monica Shaw, MD, Senior Vice President and Head of European Markets at Bristol Myers Squibb, in the press release.

The approval was based on results from the phase III KarMMa-3 study, which compared ide-cel with standard combination regimens. Ide-cel showed a progression-free survival of 13.8 months (95% CI, 11.8-16.1), compared with 4.4 months for standard regimens (95% CI, 3.4-5.8) (HR: 0.49 [95% CI, 0.38-0.63]; P<0.0001). The overall response rate was 71.3% (95% CI, 65.7-76.8) in the ide-cel group, compared with 42.4% (95% CI: 34-50.9) in the standard regimen group. Overall, ide-cel demonstrated a 51% reduction in risk of disease progression or death.

Patients treated with ide-cel experienced mostly low-grade cytokine release syndrome (CRS) and neurotoxicity. CRS of any grade occurred in 84.6% of patients treated with ide-cel, while grade ≥3 CRS occurred in 5.1% of patients.

“This expanded approval of ide-cel represents key progress in bringing a personalized therapy that delivers significantly improved, durable outcomes to patients with triple-class exposed relapsed and refractory multiple myeloma after two prior therapies,” said Paula Rodriguez-Otero, MD, PhD, the lead investigator of the KarMMa-3 trial and a Specialist in Hematology and Hemotherapy at the Clinica Universidad de Navarra, in the press release.

Read More: Paula Rodríguez Otero, MD, on Updated Ide-Cel Data From KarMMa-3 Analysis