GSK plc’s (GSK) Biologics License Application for Blenrep in combination with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for the treatment of patients with multiple myeloma is under FDA review, with a decision expected on October 23, 2025.Blenrep, as a monotherapy, was granted accelerated approval in the U.S. in August 2020 for the treatment of adult patients with relapsed or refractory multiple myeloma who had received at least four prior therapies. However, following the failure of a confirmatory trial to verify the clinical benefit demonstrated by interim data supporting Blenrep's tentative approval, the company withdrew the drug from the market in 2022.An FDA panel, which reviewed the Blenrep combinations in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, in July of this year, voted against the overall benefit/risk profile at the proposed dosage. Blenrep combinations are currently approved for the treatment of relapsed or refractory multiple myeloma in the UK, Japan, Canada, Switzerland and the United Arab Emirates.GSK closed Friday’s (September 26, 2025) trading at $39.85, up 0.84%.