Regulatory Applications Filed for Earlier Use of Idecabtagene Vicleucel

The US Food Drug Administration (FDA) has accepted a supplemental Biological License Application for idecabtagene vicleucel for earlier use in adults with triple class-exposed relapsed or refractory multiple myeloma (MM). The FDA has set a target action date of December 16, 2023.

The European Medicine Agency also validated the Type II Variation Application for idecabtagene vicleucel. The validation of the application confirms the submission is complete and initiates the procedure and scientific assessment, the manufacturer of the drug reported.

A supplemental New Drug Application was also accepted by Japan’s Ministry of Health, Labour, and Welfare.

The applications are based on interim results from the phase III KarMMa-3 trial, a randomized, controlled study designed to evaluate a chimeric antigen receptor (CAR) T-cell therapy in patients with triple class-exposed relapsed or refractory MM. For these patients, treatment options are limited, as they become triple class-exposed in earlier lines of therapy.

In the trial, researchers evaluated the therapy in patients who had received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Interim results showed that idecabtagene vicleucel significantly reduced the risk of disease progression or death versus standard regimens. The toxicity profile of the CAR T-cell therapy was consistent with previous studies.

“Positive results from our phase [III] KarMMa-3 study demonstrate a significant clinical benefit of [idecabtagene vicleucel] across lines of care in triple class-exposed multiple myeloma,” said Steve Bernstein, MD, Chief Medical Officer of 2seventy bio.

Idecabtagene vicleucel works by recognizing and binding to BCMA on the surface of MM cells, leading to CAR T-cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Source: Bristol Myers Squibb and 2seventy bio, April 2023