FDA to Review sBLA For Idecabtagene Vicleucel in the Early Treatment of Adult Patients with RRMM

The FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for idecabtagene vicleucel (Abecma; Bristol Myers Squibb) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the phase 3 study KarMMa-3. A decision on the application will not be made by the Prescription Drug User Fee Act target action date of December 16, 2023.

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Idecabtagene vicleucel is a CAR T-cell therapy that recognizes and binds to B-cell maturation antigen (BCMA) on the surface of multiple myeloma cells, leading to CAR T-cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

The KarMMa-3 study is an open-label, randomized, controlled phase 3 trial which evaluated idecabtagene vicleucel compared standard regimens in patients with RRMM who have received 2 to 4 prior lines of treatment. Previous lines' treatment had included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Enrolled patients were randomly assigned to receive idecabtagene vicleucel or standard regimens that consisted of combinations, including daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide and dexamethasone.

The ODAC will review data related to the study’s secondary endpoint, overall survival (OS). In the study, idecabtagene vicleucel demonstrated improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment. Further, the ODAC meeting will have no impact on the currently approved indication for idecabtagene vicleucel, which is for adult patients with triple-class exposed RRMM who had received 4 or more prior lines of therapy.

In addition, the KarMMa-3 study had met its primary endpoint and compared to standard regimens, idecabtagene vicleucel demonstrated a statistically significant improvement in progression-free survival, significantly reducing the risk of disease progression or death in patients with triple-class exposed RRMM. Further, safety results were consistent with the previously established safety profile.

Reported adverse effects (AEs) reported by patients who received treatment with idecabtagene vicleucel include cytokine release syndrome (CRS), neurologic toxicities, hypersensitivity reactions, infections, prolonged cytopenias, and hypogammaglobulinemia. Some of the most common nonlaboratory AEs reported include CRS, infections, fatigue, musculoskeletal pain, diarrhea, upper respiratory tract infection, nausea, viral infections, cough, headache, and decreased appetite.

Reference

Bristol Myers Squibb. Bristol Myers Squibb and 2seventy bio Provide Update on U.S. FDA Review of sBLA for Abecma (idecabtagene vicleucel) in Earlier Lines of Therapy for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma. News release. November 20, 2023. Accessed November 20, 2023. https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-and-2seventy-bio-Provide-Update-on-U.S.-FDA-Review-of-sBLA-for-Abecma-idecabtagene-vicleucel-in-Earlier-Lines-of-Therapy-for-Triple-Class-Exposed-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx