GSK plc announced the National Medical Products Administration (NMPA) of China has approved Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The approval follows priority review of the application and Breakthrough Therapy Designation for the BVd combination based on its potential to provide substantial improvement over available therapies. The Blenrep approval is supported by data from the pivotal DREAMM-7 phase III trial.
These include statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) results for the Blenrep combination versus a daratumumab-based triplet combination with bortezomib and dexamethasone (DVd). The safety and tolerability profiles of the Blenrep combination were broadly consistent with the known profiles of the individual agents. In China, the incidence of multiple myeloma has doubled to approximately 30,000 new cases annually and mortality has increased by 50% over the past three decades.
Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, which provides patients with a differentiated mechanism of action. Blenrep can be administered to a range of patient types across treatment settings as a 30-minute outpatient infusion. Blenrep is a monoclonal ADC comprising a humanised BCMA conjugated to the cytotoxic agent monomethyl 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. Blenrep is approved in the US in combination with bortezomib plus dexamethasone for the treatment of adults who have previously received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Blenrep has received more than 15 regulatory approvals in 2L+ relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone and in combination with pomalidomide and dexamethasone, including in the European Union, UK, Japan, Canada, Switzerland, Brazil and Australia.
Applications are under review in other countries globally.
