FDA Set to Review Belantamab Mafodotin Combinations for Multiple Myeloma

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The US FDA has accepted the Biologics License Application (BLA) for belantamab mafodotin (Blenrep) in combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone as a treatment for multiple myeloma patients who have already received at least one previous line of therapy. The regulatory decision was announced by GSK on Nov. 25, 2024 (1).

According to the press release, FDA’s decision was based on the positive results of two-Phase III clinical trials—DREAMM-7 and DREAMM-8. The clinical trials demonstrated statistically significant and clinically meaningful improvements in progression-free survival for patients with relapsed or refractory myeloma when treated with belantamab mafodotin combinations versus standard of care triplet combinations.

“Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration. The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival results from the DREAMM-7 trial. We look forward to working with the FDA on this review,” said Hesham Abdullah, senior vice president, global head Oncology, R&D, GSK, in the press release (1).

Multiple myeloma is a common blood cancer that is not considered to be curable. As this type of cancer can commonly become refractory to currently available treatments, the development of new approaches to treating the disease is necessary to meet clinical need (1).

Both the DREAMM-7 and DREAMM-8 clinical trials are multicenter, open-label, randomized trials. DREAMM-7 is evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib plus dexamethasone compared with the combination of daratumab and bortezomib. DREAMM-8 is evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone compared with the combination of bortezomib and pomalidomide plus dexamethasone. Results from the DREAMM-7 (2) and DREAMM-8 (3) clinical trials have already been presented at the American Society of Clinical Oncology meetings and published in the New England Journal of Medicine.

Belantamab mafodotin is an antibody-drug conjugate that is comprised of a humanized B-cell maturation antigen monoclonal antibody conjugated by a non-cleavable linker to the cytotoxic agent auristatin F. The therapy, in the above-mentioned combinations for the treatment of relapsed/refractory multiple myeloma, has already been accepted for review in the European Union, Japan, United Kingdom, Canada, and Switzerland. Additionally, the therapy in combination with bortezomib and dexamethasone has been granted Breakthrough Therapy Designation and priority review in China, and in Hong Kong, it has been approved as a monotherapy.

References

1. GSK. Blenrep Combinations Accepted for Review by the US FDA for the Treatment of Relapsed/Refractory Multiple Myeloma. Press Release, Nov. 25, 2024.
2. GSK. DREAMM-7 Phse III Trial Shows Blenrep Combination Nearly Tripled Median Progression-Free Survival Versus Standard of Care Combination in Patients with Relapsed/Refractory Multiple Myeloma. Press Release, Feb. 5, 2024.
3. GSK. Blenrep Combination Reduced the Risk of Disease Progression or Death by Nearly 50% Versus Standard of Care Combination in Relapsed/Refractory Multiple Myeloma. Press Release, June 2, 2024.