GSK (GSK) plc announced the U.S. Food and Drug Administration has extended the review period for the Biologics License Application for Blenrep combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The new Prescription Drug User Fee Act, or PDUFA, action date is October 23, 2025 and provides the FDA with time to review additional information provided in support of the application, the company stated. “GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review. Blenrep combinations are currently approved in the UK, Japan, Canada, Switzerland (DREAMM-8 only at this time) and the United Arab Emirates. Applications are currently under review in all major markets globally, including the EU and China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application),” the company added.
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