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GSK PLC on Thursday noted that the US Food & Drug Administration Oncologic Drugs Advisory Committee voted against the overall benefit/risk profile at the proposed dosage of Blenrep combinations. Blenrep, also known as belantamab mafodotin, is a treatment for adults with relapsed or refractory multiple myeloma, a form of blood cancer. The benefit/risk profile gauges the benefit of a drug or treatment versus its potential risks. The FDA said Thursday: ‘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 said the Blenrep combinations rejected by the FDA committee were evaluated in adults with the form of blood cancer who have received at least one prior line of therapy. The FDA will consider the recommendation of the committee and will decide by next week Wednesday. Blenrep combinations are approved in relapsed or refractory multiple myeloma in the UK, Japan and Switzerland. ‘GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival,’ GSK said. GSK shares had closed 0.7% lower at 1,411.00 pence each on Thursday in London for a market capitalisation of $74.00 billion. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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