(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) announced that the U.S. FDA Oncologic Drugs Advisory Committee has voted 12-0 in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma. Two committee members could not participate in the final vote.
The recommendation was based on review of DREAMM clinical trial programme, including the pivotal DREAMM-2 study.
The company said it looks forward to working with the FDA as they complete their review of Biologics License Application. The company added that, if approved, belantamab mafodotin will be a first-in-class anti-BCMA therapy for the treatment of relapsed/refractory multiple myeloma.
The FDA granted breakthrough therapy designation to belantamab mafodotin in 2017 and priority review designation for BLA earlier this year.
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