GSK fails to gain FDA advisers backing for cancer therapy
GSK plc has announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of Blenrep (belantamab mafodotin-blmf) combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July 2025 PDUFA date.
"GSK remains confident in the benefit/risk profile of Blenrep (belantamab mafodotin-blmf) and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival," the company stated.
Blenrep combinations are approved in relapsed or refractory multiple myeloma in the UK and Japan, as well as other markets, including Switzerland (based on the results of DREAMM-8). Applications are currently under review in all major markets globally, including the European Union, and China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. Multiple myeloma is a significant and enduring health concern in the US, where more than 35,000 cases were diagnosed in 2024. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.
