Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma

Core Insights - The US FDA has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for treating adult patients with relapsed or refractory multiple myeloma who have undergone at least two prior lines of therapy [1][14][6] Group 1: Approval and Clinical Data - Blenrep's approval is based on the DREAMM-7 phase III trial, which showed a 51% reduction in the risk of death (HR 0.49) and a tripled median progression-free survival (PFS) of 31.3 months compared to 10.4 months for a daratumumab-based triplet [2][6][10] - The safety profile of the Blenrep combination aligns with the known profiles of the individual agents, indicating manageable side effects [2][6] Group 2: Market Need and Accessibility - There is a significant unmet need for new therapies in multiple myeloma, as nearly all patients experience relapse, and existing treatments often lead to suboptimal outcomes [3][6] - Blenrep is the only anti-BCMA agent accessible in community settings, where approximately 70% of patients receive care, fulfilling a major patient need [3][6] Group 3: Ongoing Development and Future Trials - GSK is advancing the DREAMM clinical program to explore Blenrep's efficacy in earlier lines of treatment, with follow-up data expected in early 2028 [7][6] - DREAMM-10, a phase III trial for newly diagnosed transplant-ineligible patients, was initiated in Q4-2024, with interim efficacy data anticipated in early 2028 [7][12] Group 4: Global Approvals and Future Applications - Blenrep has received approvals in multiple markets, including the European Union, UK, Japan, Canada, Switzerland, and Brazil, with applications under review in other regions, including China [8][6]