By Fineline Cube 
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced today that Blenrep has received European Union (EU) approval for two indications: in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy; or in combination with pomalidomide and dexamethasone (BPd) for adult patients with RRMM who have received at least one prior therapy, including lenalidomide-containing treatment.
Drug Mechanism and Technology
Blenrep is an antibody-drug conjugate (ADC) that combines a humanized anti-BCMA monoclonal antibody with the cytotoxic agent auristatin F via a non-cleavable linker. The linker technology is licensed from Seagen Inc., while the monoclonal antibody is produced using POTELLIGENT technology licensed from BioWa Inc., a subsidiary of Kyowa Kirin Group.
Clinical Trial Results
The DREAMM-7 and DREAMM-8 studies demonstrated that Blenrep-related ocular side effects can be effectively managed and reversed through appropriate dose adjustments and follow-up. Discontinuation rates due to ocular side effects were low (≤9%). The most commonly reported non-ocular adverse events (incidence >30%) were thrombocytopenia (87%) and diarrhea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%), and COVID-19 infection (37%) in DREAMM-8.
Global Approval and Market Expansion
Blenrep combination regimens have also been approved in the UK, Japan, and other markets, including Canada and Switzerland. These approvals are based on the DREAMM-8 study results. The regimen is currently under review in all major global markets, including the U.S. and China. In the U.S., the combination therapy received breakthrough therapy designation and its marketing application was granted priority review status based on DREAMM-7 results.-Fineline Info & Tech