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GSK PLC said Thursday its drug Blenrep has been approved by the US Food & Drug Administration for the treatment of adults with relapsed or refractory multiple myeloma, the third most common blood cancer globally. The London-based pharmaceuticals firm GSK said the FDA approved Blenrep for use in combination with the drugs bortezomib and dexamethasone to treat patients who have received at least two prior lines of therapy. The decision was based on phase III Dreamm-7 trial data, which showed a 51% reduction to the risk of death and tripled the time patients lived without the disease progressing. This was compared to a different drug combination, which included daratumumab. Blenrep was previously withdrawn from the US market in 2022, after the outcome of the Dreamm-3 phase III trial failed to meet FDA requirements. GSK said that approximately 70% of patients with multiple myeloma in the US are treated in a community cancer setting. The company said this ‘leaves an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.’ GSK said that Blenrep is available through a new, streamlined risk evaluation and mitigation strategy. This is to support appropriate use and patient safety, while reducing the administrative burden. Chief Scientific Officer Tony Wood said: ‘Today’s FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients. There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse and re-treating with the same mechanism of action often leads to suboptimal outcomes. ‘As the only anti-BCMA agent that can be administered across healthcare settings, including in community centres where 70% of patients receive care, Blenrep fulfils a major patient need. We believe Blenrep can redefine treatment for patients with multiple myeloma in all parts of the world, and we are accelerating its development in earlier lines of therapy to support its use across all stages of this difficult-to-treat cancer.’ Shares in GSK were down 1.5% to 1,621.40 pence on Friday morning in London. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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