A panel of advisors to the FDA voted 12 to 0 on Tuesday that the benefits of GlaxoSmithKline's BCMA-directed antibody-drug conjugate (ADC) belantamab mafodotin outweigh the risks for the proposed patient population with relapsed or refractory multiple myeloma (RRMM). The drugmaker is seeking to have the treatment approved for adults with RRMM who received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
Axel Hoos, head of oncology R&D at the UK drugmaker, said "we are pleased the committee recognised the potential for belantamab mafodotin to help patients who have RRMM, an incurable disease with limited treatment options. We look forward to working with the FDA as they complete their review."
The panel vote follows a recent FDA staff report that questioned whether the drug's benefits exceed the potential risk of ocular toxicity seen in the pivotal DREAMM-2 trial. They noted that keratopathy was the most common adverse event reported in the study, with an overall incidence of 71%, while 44% of patients experienced at least one episode of severe keratopathy at the 2.5 mg/kg dose.
GlaxoSmithKline had argued that corneal changes are a known class-effect of BCMA-directed ADCs and can be managed in part with dose modifications, adding they "do not appear to result in permanent sequalae," although the FDA said this could depend on events being caught early. For related analysis, see ViewPoints: Safety of GSK's big myeloma hope scrutinised by FDA.
Meanwhile, GlaxoSmithKline reiterated that if approved, belantamab mafodotin would be a first-in-class anti-BCMA therapy for the treatment of RRMM. The company added that a marketing application for belantamab mafodotin is also under accelerated assessment by the European Medicines Agency.
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