---

The US Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for GSK’s brand of belantamab mafodotin (Blenrep).

The biologic has been accepted in combination with bortezomib plus dexamethasone (BorDex) and pomalidomide plus dexamethasone (PomDex) for the management of refractory myeloma, the third most common blood cancer worldwide.

Belantamab mafodotin is an antibody-drug conjugate composed of a humanized B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F through a non-cleavable linker.

The therapy has gained regulatory filing acceptance in five other territories, including the United Kingdom, the European Union, Canada, Switzerland, and Japan, for treatment of multiple myeloma.

This acceptance is based on results from two phase III trials coded DREAMM-7 and DREAMM-8 that demonstrated clinically meaningful and statistically significant improvements in progression-free survival in patients with relapsed or refractory multiple myeloma.

---

READ ALSO: Japan approves first RSV vaccine for adults aged 50 -59

---

In key secondary endpoints, both studies demonstrated deeper and more lasting responses in the belantamab mafodotin combination compared to the respective standard therapies, with DREAMM-7 showing statistically significant and clinically meaningful overall survival benefit with the new therapy.

“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," stated Hesham Abdullah, Global Head of Oncology, R&D, GSK.

In both studies, the belantamab mafodotin combinations' safety and tolerability profiles were mostly in line with the established profiles of the individual therapies.

Presentations of the analysis's efficacy and safety findings will take place on December 9, 2024, at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH).

GSK will be hoping for a favorable outcome from the US FDA with the final decision expected on 23 July 2025.

---

Did you find this informative? Subscribe for more.

---