On November 30, 2024, the U.S. Food and Drug Administration (FDA) granted full approval to Teclistamab, a bispecific CD3xBCMA T-cell engager, for the treatment of relapsed or refractory multiple myeloma. The decision follows compelling data from the MajesTEC-1 trial, which showed sustained responses in patients who had exhausted multiple lines of therapy.

Teclistamab, developed by Johnson & Johnson, targets both CD3 on T cells and BCMA on myeloma cells, redirecting immune activity to eliminate malignant plasma cells. The drug had previously received accelerated approval in 2022, but the latest data confirmed its efficacy and safety profile, paving the way for full regulatory endorsement.

In the pivotal Phase II study, patients treated with Teclistamab achieved an overall response rate of 63%, with a median duration of response exceeding 18 months. Notably, the trial enrolled individuals who had received at least four prior therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies.

The FDA’s review also included updated safety data, which highlighted manageable cytokine release syndrome and low rates of neurotoxicity. The approval adds to a growing arsenal of bispecific antibodies reshaping the treatment landscape for hematologic malignancies.

Dr. Nicole Gormley, Director of the FDA’s Division of Hematologic Malignancies, stated: “Teclistamab represents a significant advancement for patients with limited options. Its durable responses and manageable safety profile make it a valuable addition to the myeloma toolkit.”

With full approval secured, Johnson & Johnson plans to expand access through specialty infusion centers and explore combination strategies with other immunotherapies. Analysts expect Teclistamab to become a cornerstone in late-line myeloma treatment, especially as bispecifics gain traction across oncology.