FDA committee backs GSK’s belantamab mafodotin in relapsed or refractory multiple myeloma
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has moved to recommend the use of GlaxoSmithKline’s belantamab mafodotin, or GSK2857916 as it is also known, as a monotherapy in the treatment of relapsed or refractory multiple myeloma, the pharma company reported.
The committee voted 12-0 in favour of recommending the therapy due to its positive benefit/risk profile based on supplied six-month efficacy data, though it was noted that two committee members were unable to take part in the final vote.
The reviewed indication relates specifically to patients who have previously received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
“We are pleased the committee recognised the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options,” remarked GSK’s Dr Axel Hoos, Senior Vice President and Head of Oncology R&D. “We look forward to working with the FDA as they complete their review of our Biologics License Application.”
Belantamab mafodotin has not yet secured approval in any global market, but this recommendation could change that. Though the FDA is not obligated to follow the recommendation of its committee, it often follows its advice. GSK confirmed that the drug is also undergoing review by the European Medicines Agency.
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