GSK has received regulatory approval in the United Kingdom for two new combination therapies featuring its antibody-drug conjugate (ADC) Blenrep, marking a significant step in the drug’s return to the market following its previous withdrawal.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorized the use of Blenrep (belantamab mafodotin) in combination with either bortezomib and dexamethasone, or pomalidomide and dexamethasone, for the treatment of relapsed or refractory multiple myeloma in adults who have received at least one prior line of therapy.
The decision is based on late-stage clinical trial data showing that these combinations improved progression-free survival and, in some cases, overall survival compared to standard-of-care regimens.
This marks a major milestone for Blenrep, which was pulled from global markets, including the U.S., in 2022 after a Phase 3 trial found it was not superior to existing therapies when used as a monotherapy. The MHRA approval supports its reintroduction in combination settings and signals renewed potential for the drug within GSK’s oncology pipeline.
Blenrep is part of the growing class of antibody-drug conjugates—engineered antibodies linked to cytotoxic agents that selectively target tumor cells while limiting off-target effects often associated with conventional chemotherapy.
GSK emphasized that the latest approvals position Blenrep for renewed growth, with regulatory reviews for the new combination regimens currently underway in 14 additional countries. The company also anticipates further approvals later this year.
The inclusion of established therapies such as bortezomib (a proteasome inhibitor), pomalidomide (an immunomodulatory agent), and the corticosteroid dexamethasone reflects a strategic approach to integrating Blenrep into existing treatment frameworks for multiple myeloma.
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