Abecma is a BCMA-targeted CAR-T cell therapy

Abecma is a BCMA-targeted CAR-T cell therapy

Abecma is a BCMA CAR-T therapy

Abecma is a first-in-class, BCMA-directed, personalized immune cell therapy. BCMA is a protein that is nearly universally expressed on multiple myeloma cancer cells. As an anti-BCMA CAR-T cell therapy, Abecma recognizes and binds to BCMA, leading to the death of cells expressing BCMA.

Regulatory Approval Overview for Abecma

Abecma was the first BCMA CAR-T cell therapy to receive regulatory approval worldwide, being approved in the United States in March 2021, in the European Union in August 2021, in Japan on January 20, 2022, and again approved by the U.S. Food and Drug Administration (FDA) on April 5, 2024, for the treatment of relapsed or refractory multiple myeloma after one or more prior lines of therapy.

The approval of Abecma provides patients with relapsed or refractory multiple myeloma (R/R MM) a new, effective, and personalized treatment option, requiring only a single infusion to achieve rapid, deep, and durable remission. In clinical trials, Abecma has demonstrated a favorable safety profile in treated patients, with cytokine release syndrome (CRS) and neurotoxicity (NT) mostly being low-grade, predictably occurring early, and rapidly resolving.

Mechanism of Action for Abecma

Abecma works by engineering a patient’s T cells to express a receptor specific for BCMA. The manufacturing process involves isolating T cells from each patient’s blood, modifying the T cells using a lentiviral vector encoding the BCMA-targeted chimeric antigen receptor, resulting in the expression of the BCMA receptor on the T cell surface. During treatment, MM patients first receive a lymphodepleting regimen of chemotherapy drugs (cyclophosphamide and fludarabine) to eliminate existing T cells, followed by the infusion of Abecma. Once infused back into the patient, Abecma can then seek out and kill cells expressing BCMA.