Overview
- The FDA cleared belantamab mafodotin (Blenrep) only with bortezomib and dexamethasone for adults who have received at least two prior therapies, rejecting a second proposed regimen and earlier-line use.
- Approval rested on phase 3 DREAMM-7 results showing about a 51% reduction in risk of death and median progression-free survival of 31.3 months versus 10.4 months for a daratumumab-based comparator.
- Labeling includes a boxed warning and a Risk Evaluation and Mitigation Strategy to address significant ocular toxicity and other safety risks observed in trials.
- The decision followed an FDA advisory committee vote against the overall benefit–risk profile for the proposed combinations earlier this year, reflecting continued caution on dosing and tolerability.
- GSK shares slipped after the ruling as analysts flagged constrained U.S. uptake in a crowded BCMA landscape, even as the company highlights delivery across community care settings as a practical advantage.