(Il Sole 24 Ore Radiocor) - Milano, 20 apr - The UK pharmaceutical company GSK said 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.

(RADIOCOR) 20-04-26 08:43:31 (0124) 5 NNNN