FDA Panel Unanimously Supports Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma

The Food and Drug Administration (FDA)’s Oncologic Drugs Advisory Committee (ODAC) unanimously voted 12 to 0 in favor of the agency approving belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma who have previously received at least four therapies.

The purpose of the Oncologic Drugs Advisory Committee (ODAC) is to review and evaluate data concerning the safety and effectiveness of marketed and investigational human drug products for their use in the treatment of cancer. In turn, the committee makes appropriate recommendations to the FDA’s commissioner.

For this meeting, the committee was tasked to assess whether the risk of ocular toxicity had been adequately identified in the DREAMM-2 trial and if the risk of ocular toxicity associated with belantamab mafodotin — an investigational anti-B-cell maturation antigen monoclonal antibody-drug conjugate – outweighed its benefit.

Keratopathy, or damage to the cornea, symptoms of blurred vision and dry eyes were the most notable side effects associated with the therapy, according to a briefing the FDA released before the meeting.

"It seems clear that this is an active agent," ODAC chairperson Dr. Philip C. Hoffman, a professor of medicine at University of Chicago Medicine, said during the hearing. "The toxicity is certainly not life threatening; in many instances, it isn't even comfort threatening, though evident on examinations. I do think patients are probably willing to take this risk, and the mitigation strategy that the company has outlined for thorough exams before each dosing, a grading system, and so on, addresses the concerns."

The FDA in January granted a priority review to belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma.

“I think the efficacy and toxicity remains favorable in the highly pretreated patient population that was studied,” Dr. Heidi D. Klepin, a professor of hematology and oncology at Wake Forest School of Medicine, said. "I think the informed consent process will allow patients to choose whether this tradeoff is worth it to them. I would encourage the sponsor to really put some additional effort into enrolling and reporting on a representative number of patients aged 75 or older, since that particular subgroup was poorly represented and is a large and growing group of patients who may have this choice. At present, we don't have enough evidence on the benefit to risk ratio in that patient population."

The FDA’s ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. While the agency considers these panel recommendations, of note, the FDA solely makes the final decision regarding the approval of agents and the recommendations by the panel are non-binding.

A version of this story originally appeared on OncLive® as “FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma.”

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