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GSK PLC on Thursday said its Blenrep blood cancer treatment has been approved in Europe, as it awaits a final decision from the US regulator. The London-based pharmaceutical firm said that EU approval was based on ‘superior efficiency’ results for the drug in third-phase adult trials. Blenrep, or belantamab mafodotin, was tested in combination with bortezomib plus dexamethasone and pomalidomide plus dexamethasone. The patients surveyed where adults with relapse or refractory myeloma, a type of blood cancer, who had received previous treatment. Maria-Victoria Mateos, the principal investigator, said: ‘With the approval of Blenrep combinations in the EU, we now have additional tools in our efforts to keep patients in remission longer, maintain quality of life and extend survival.’ GSK added: ‘Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes.’ However, the drug is linked to eye-related side effects, which GSK says are manageable and reversible. Blenrep is currently approved for use in the UK, Japan, Canada and Switzerland. Applications are under review in the US and China. On Wednesday, GSK said the US Food & Drug Administration had extended the review period for Blenrep, after an initial negative vote suggesting the drug was unlikley to be approved. The FDA said earlier in July: ‘The key safety issue with belantamab mafodotin is ocular toxicity, including keratopathy (changes in the corneal epithelium), visual acuity changes, and other ocular symptoms, such as blurred vision and dry eye.’ GSK shares were up 0.1% at 1,392.00 pence on Friday morning in London. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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