GSK provides update on US FDA advisory committee review of Blenrep

GSK (GSK) notes that the U.S. FDA Oncologic Drugs Advisory Committee voted against the overall benefit/risk profile at the proposed dosage of Blenrep combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the July 23 PDUFA date. GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival.