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The FDA on Wednesday in heavily pretreated multiple myeloma.

Belantamab mafodotin is the first approved therapy that targets B-cell maturation antigen (BCMA), and is indicated for patients that failed a minimum of four prior agents, including an immunomodulatory agent, an anti-CD38 monoclonal antibody, and a proteasome inhibitor.

Support for the anti-BCMA drug's approval came from 97 relapsed or refractory multiple myeloma patients treated at a dose of 2.5 mg/kg every 3 weeks in the single-arm DREAMM-2 trial. These patients had failed a median of seven prior lines of treatment, and 31% (97.5% CI 21%-43%) responded to treatment with belantamab mafodotin. At 6 months, the median duration of response had not been reached, and 73% had responses lasting at least 6 months.

"While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care," DREAMM-2 leader Sagar Lonial, MD, of the Winship Cancer Institute of Emory University in Atlanta, said in a . "Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of Blenrep, the first anti-BCMA therapy, is significant for both patients and physicians alike."

Accelerated approval of belantamab mafodotin came following unanimous support from the Oncologic Drugs Advisory Committee last month, which, despite concerns over ocular toxicity, agreed that the benefits of treatment outweighed potential risks. More than 70% of patients developed keratopathy and corneal changes. While these events resolved in most cases, a few (2.1%) permanently discontinued treatment due to this toxicity. Full approval of the drug could be contingent on clinical outcomes in the requisite confirmatory trials.

Due to the risk of ocular toxicity, FDA included a boxed warning and the drug will be distributed through a Risk Evaluation and Mitigation Strategy (REMS).

Other common adverse events in DREAMM-2 included decreased visual acuity in 53%, nausea in 24%, blurred vision in 22%, pyrexia in 22%, infusion-related reactions in 21%, and fatigue in 20%.

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