UK-based pharmaceutical giant UK-based pharmaceutical company GlaxoSmithKline (GSK, NYSE: GSK) has announced the receipt of marketing approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin). The approval allows Blenrep to be used in combination with bortezomib plus dexamethasone (BVd) for adults with multiple myeloma (MM) who have received at least one prior therapy, and with pomalidomide plus dexamethasone (BPd) for patients who have received at least one prior therapy including lenalidomide. This marks the first global approval for Blenrep in these specific treatment settings.
Clinical Trial Evidence
The MHRA’s decision is supported by data from the pivotal DREAMM-7 and DREAMM-8 Phase III trials. These trials demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) for Blenrep combinations compared to standard triplet therapies in the second-line or later treatment of MM. The results highlight Blenrep’s potential to enhance treatment outcomes for patients with relapsed or refractory multiple myeloma.
Blenrep’s Mechanism and Technology
Blenrep is an ADC consisting of a humanized BCMA monoclonal antibody linked to the cytotoxic agent auristatin F via a non-cleavable linker. The drug’s linker technology is licensed from Seagen Inc., and the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group. This innovative technology enables targeted delivery of chemotherapy to cancer cells, minimizing systemic toxicity.-Fineline Info & Tech