23rd Jul 2025 19:52
(Alliance News) - GSK PLC on Wednesday said the US Food & Drug Administration has extended the review period for Blenrep combinations in relapsed/refractory multiple myeloma after an advisory committee last week voted against the overall benefit/risk profile of the drug.
Last Thursday, 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 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.
On Wednesday, GSK, the London-based pharmaceuticals firm, said the new Prescription Drug User Fee Act action date is October 23 and provides the FDA with time to review additional information provided in support of the Biologics License Application.
The BLA is supported by efficacy results shown by Blenrep combinations in the pivotal Dreamm-7 and Dreamm-8 phase III trials in relapsed or refractory multiple myeloma.
These include statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival versus a daratumumab-based triplet in Dreamm-7.
The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.
GSK said it is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review.
Blenrep combinations are currently approved in the UK, Japan, Canada, Switzerland and the United Arab Emirates.
Shares in GSK closed up 1.6% at 1,369.00 pence each in London on Wednesday.
By Jeremy Cutler, Alliance News reporter
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