Overview

• The UK’s MHRA has approved Blenrep in combination with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for adults with relapsed or refractory multiple myeloma who have undergone at least one prior therapy.
• This marks the first worldwide regulatory approval for Blenrep in these combination regimens, establishing a significant milestone for GSK’s oncology portfolio.
• The decision follows positive results from the DREAMM-7 and DREAMM-8 Phase 3 trials, which demonstrated significant improvements in progression-free survival and overall survival compared to standard treatments.
• Blenrep, an antibody-drug conjugate targeting the BCMA protein on myeloma cells, was previously withdrawn from the U.S. market in 2022 after failing a confirmatory trial but has been repositioned in combination therapies.
• Regulatory reviews for Blenrep combinations are ongoing in 14 countries, including the U.S., with a key FDA decision expected by July 2025.