The United States Food and Drug Administration (FDA) has officially approved Blenrep (belantamab mafodotin-blmf) as a treatment for adult patients with relapsed or refractory multiple myeloma. This approval specifically targets those who have undergone at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Key Findings from DREAMM-7 Trial
The approval is supported by compelling results from the pivotal DREAMM-7 phase III clinical trial. In this study, Blenrep was evaluated in combination with bortezomib and dexamethasone (BVd) compared to a daratumumab-based triplet (DVd). Notably, the Blenrep combination demonstrated:
- A 51% reduction in the risk of death (HR 0.49, 95% CI: 0.32-0.76).
- A median progression-free survival (PFS) of 31.3 months, tripling the previous standard of care’s PFS of 10.4 months.
Significance in the Treatment Landscape
According to Tony Wood, Chief Scientific Officer of GSK, this approval marks a significant advancement in treatment options for multiple myeloma patients. Nearly all patients with this condition face relapse, making the need for innovative therapies urgent. Blenrep is unique as it is the only anti-B-cell maturation antigen (BCMA) therapy accessible in community settings, where approximately 70% of patients receive care.
The FDA has also introduced a new streamlined Risk Evaluation and Mitigation Strategy (REMS) for Blenrep. This initiative facilitates patient access while ensuring safety and reducing administrative burdens. Enhanced communication between healthcare professionals and eye specialists is part of the strategy, addressing potential side effects like ocular issues.
Future Prospects for Blenrep
GSK has plans to expand clinical development of Blenrep for earlier lines of treatment, including in newly diagnosed patients. The DREAMM-10 trial, focusing on newly diagnosed patients who are ineligible for autologous stem cell transplantation, is set to begin enrollment in late 2024. Results from this study are anticipated by early 2028.
Global Approvals and Ongoing Research
Blenrep has also received approvals in several countries, including the European Union, Canada, and Japan, for use in relapsed or refractory multiple myeloma. Applications are currently under review in additional regions, including China, where it has received Breakthrough Therapy Designation.
Understanding Multiple Myeloma
Multiple myeloma is characterized as the third most common blood cancer worldwide, with around 180,000 new cases diagnosed each year. Although treatable, the condition remains incurable, underscoring the need for innovative treatment options. GSK’s ambition is to improve patient outcomes and quality of life by expanding treatment options for this challenging disease.
With Blenrep’s recent FDA approval, patients battling relapsed or refractory multiple myeloma now have access to a promising new therapy that addresses significant unmet needs in their treatment journey.
