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GSK PLC on Friday said its drug Blenrep has received a ‘positive opinion’ from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The London-based pharmaceutical company said the committee has recommended the approval of belantamab mafodotin, brand name Blenrep, for the treatment of adults with relapsed or refractory multiple myeloma, a form of cancer. The drug was recommended for approval in combination with bortezomib plus dexamethasone in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone in patients who have received at least one prior therapy including lenalidomide. GSK said it expects the drug to be approved by the European Commission in the third quarter of 2025. The drug was previously approved in the UK in April and Japan earlier in May. Blenrep showed ‘superior efficacy results’ in phase three trials in relapsed or refractory myeloma. ‘Today’s positive CHMP opinion is an important milestone toward bringing the benefits of Blenrep combinations to patients with multiple myeloma in Europe,’ said Senior Vice President Hesham Abdullah. ‘Blenrep is well positioned to address the unmet needs of these patients while also providing the benefit of in-office administration in both academic and community treatment settings without complex pre-administration regimens or hospitalisation.’ GSK added that Blenrep combinations are currently under review in all major global markets incuding the US, China, Canada and Switzerland. Shares in GSK were up 0.2% to 1,431.50 pence in London on Friday afternoon. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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