FDA Delays Blenrep Decision, Challenging GSK’s Multiple Myeloma Comeback Plans
The FDA has extended its review of GSK's Blenrep (belantamab mafodotin-blmf) for multiple myeloma combinations, moving the Prescription Drug User Fee Act (PDUFA) action date from July 23, 2025, to October 23, 2025135.
This delay follows an FDA advisory committee's rejection of the risk-benefit profile for Blenrep combinations, citing concerns over high rates of ocular toxicity (e.g., keratopathy, corneal ulcers), safety, and dosing in clinical trials234.
GSK was seeking U.S. approval for Blenrep in combination with Takeda's Velcade and dexamethasone, and Bristol Myers Squibb's Pomalyst and dexamethasone, for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy23.
The committee voted 5-3 against the Velcade combo and 7-1 against the Pomalyst combo, primarily due to safety and dosing concerns3.
Despite the setback in the U.S., Blenrep has shown strong efficacy in trials (e.g., DREAMM-7, DREAMM-8) and was approved by the European Medicines Agency in May 20251.
The delay highlights ongoing challenges for GSK in balancing promising oncology assets with regulatory scrutiny, forcing the company to diversify its pipeline and revisit dosing strategies1.
Sources:
1. https://www.ainvest.com/news/gsk-blenrep-regulatory-hurdles-calculus-shareholder-2507/
2. https://www.fiercepharma.com/pharma/fda-advisors-spurn-gsks-blenrep-comeback-dreams-safety-trial-concerns
3. https://www.managedhealthcareexecutive.com/view/fda-extends-review-of-blenrep-combinations-in-multiple-myeloma
4. https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-us-fda-advisory-committee-review-of-blenrep-belantamab-mafodotin-blmf-combinations-for-patients-with-relapsedrefractory-multiple-myeloma/
5. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-extension-of-us-food-and-drug-administration-review-period-for-blenrep-belantamab-mafodotin-blmf-in-relapsedrefractory-multiple-myeloma/