The U.S. Food and Drug Administration has approved a new treatment combination of teclistamab‑cqyv with daratumumab and hyaluronidase‑fihj for adult patients with relapsed or refractory Multiple Myeloma. The approval offers a new therapeutic option for patients whose disease has returned or stopped responding after earlier treatments.
The combination brings together two targeted immunotherapies that work through different mechanisms to attack cancer cells. Teclistamab is a bispecific antibody that directs the body’s T-cells to recognize and destroy myeloma cells by targeting B-cell maturation antigen (BCMA). Daratumumab, meanwhile, targets the CD38 protein found on the surface of myeloma cells, helping the immune system eliminate them.
The regulatory decision was supported by results from the Phase 3 MajesTEC-3 clinical trial, which evaluated patients with relapsed or refractory multiple myeloma who had previously received one to three lines of therapy. In the study, the teclistamab-based regimen demonstrated significantly improved progression-free survival compared with standard treatment combinations.
Researchers believe the dual-target strategy may enhance anti-tumor activity by simultaneously engaging immune cells and directly targeting malignant plasma cells. Earlier studies had already suggested that the two drugs could work synergistically, potentially improving treatment responses in difficult-to-treat cases of the disease.
Teclistamab itself previously received accelerated approval in 2022 as the first BCMA-directed bispecific antibody for adults with heavily pretreated relapsed or refractory multiple myeloma. The new approval expands its role when used in combination therapy, offering clinicians another promising option in the evolving treatment landscape of this blood cancer.
