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FDA Accepts BLA for GSK’s Blenrep® Combination Treatment for Multiple Myeloma

Nov 25, 2024

On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus dexamethasone) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy.  Both combination treatments were accepted for review in Japan in September 2024 and the BorDex combination was granted Breakthrough Therapy Designation (BTD) in China in September 2024.  BlenRep is approved as a monotherapy in Hong Kong. 

This follows GSK’s announcement a week earlier of positive results demonstrating that Blenrep® in combination with BorDex reduced the risk of death when compared with standard of care.