WASHINGTON, 10-31-25 – The U.S. Food and Drug Administration approved a combination therapy including belantamab mafodotin (Blenrep) for adults with multiple myeloma whose disease has returned or worsened despite two earlier treatments.
Belantamab is an antibody-drug conjugate, which combines the power of chemotherapy with an antibody against B-cell maturation antigen (BCMA), to deliver the chemotherapy directly to myeloma cells. In this latest approval, belantamab will be used in combination with bortezomib (Velcade) and dexamethasone, which also trigger the death of myeloma cells.
“We have made great strides in the treatment of multiple myeloma, but this new treatment option is good news for patients whose multiple myeloma has returned after earlier treatments, which is still all too common,” says Lore Gruenbaum, Ph.D., Blood Cancer United® Chief Scientific Officer.
In the trial that the FDA reviewed to approve the new combination, its efficacy was measured by progression-free survival, overall survival, and the duration of response to the treatment.
Patients who received the three-drug combination had a 51% reduction in the risk of death and three-times longer progression-free survival time (31.3 months) compared to patients treated with another FDA-approved, commonly used drug combination.
Another treatment combination, containing belantamab together with pomalidomide (Pomalyst) and dexamethasone, was also reviewed but not approved by FDA.
Belantamab as a single drug received accelerated approval by the FDA in 2020 but was voluntarily withdrawn from the market in 2022 when additional clinical trials failed to confirm its benefit.
In the latest reviews by FDA and a panel of experts, potential treatment side effects, including ocular (eye) toxicity, were closely evaluated. In the end, the FDA decided the benefits of having the drug combo available for people facing this serious cancer outweighed the risks.
“The FDA’s decisions highlight an important point. Cancer is a serious, complex and challenging disease to treat and requires treatments that may come with serious side effects,” says Dr. Gruenbaum. “Sometimes that’s a necessary trade off, but we are working to change that for as many blood cancers as we can, by finding more targeted therapies that work against cancer, while causing fewer side effects and being better tolerated by patients."