GSK’s Blenrep (belantamab mafodotin) combinations have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat multiple myeloma in adults.
The drug has been authorised alongside bortezomib plus dexamethasone (BVd) to treat patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) to treat those who have received at least one prior therapy including lenalidomide.
Approximately 6,500 new cases of multiple myeloma, a type of blood cancer that develops in plasma cells in the bone marrow, are diagnosed in the UK each year. Despite available treatments, most patients experience relapse, with only 55% in the UK remaining alive five years after diagnosis.
GSK’s Blenrep is the only B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate for multiple myeloma, offering patients a differentiated mechanism of action. Blenrep combinations can also be given in any oncology treatment setting without hospitalisation or complex pre-administration regimens.
The MHRA’s authorisation marks the first in the world for Blenrep in this treatment setting and is supported by results from the phase 3 DREAMM-7 and DREAMM-8 trials in relapsed or refractory multiple myeloma.
Both studies demonstrated statistically significant and clinically meaningful progression-free survival improvements for the Blenrep combinations compared to standard-of-care triplet combinations, with DREAMM-7 meeting the key secondary endpoint of overall survival.
Blenrep was also associated with clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses, and the safety and tolerability profiles of the combinations were “broadly consistent” with the known profiles of the individual agents, GSK said.
Hesham Abdullah, senior vice president, global head oncology, research and development, GSK, described the approval as a “transformative milestone for patients with multiple myeloma”.
“As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase 3 data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse,” Abdullah said.
Blenrep combinations are currently under review in 14 countries including the US, where a Prescription Drug User Fee Act date of 23 July 2025 has been given, and the EU.