BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - GSK plc (GSK, GSK.L) issued an update on FDA advisory committee review of Blenrep combinations for patients with relapsed/refractory multiple myeloma. GSK said it remains confident in the benefit/risk profile of Blenrep or belantamab mafodotin-blmf 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.
The FDA Oncologic Drugs Advisory Committee voted against the overall benefit/risk profile at the proposed dosage of Blenrep combinations. The FDA will consider the recommendation of the committee as it finalises review on Blenrep in advance of the 23 July 2025 PDUFA date.
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