GSK’s Blenrep combination approved by Japan MHLW

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved UK pharma major GSK’s (LSE: GSK) Blenrep (belantamab mafodotin) combination for the treatment of adults with relapsed or refractory multiple myeloma.

The approval, which marks the second regulatory authorization for the drug, is based on positive results from the DREAMM-7 and DREAMM-8 Phase III trials evaluating Blenrep in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd), respectively, in patients with multiple myeloma who have received at least one prior therapy. The approval follows an orphan drug designation for Blenrep in Japan, which was granted based on its ability to address high unmet need for patients with multiple myeloma.

GSK pulled Blenrep off the US market in November 2022, after in failed to produce confirmatory data to get the drug’s accelerated approval converted to regular approval. But the company has since tried to re-establish the drug with new clinical data.