GSK Blenrep combos receive positive EMA Committee opinion in relapsed/refractory multiple myeloma
GSK plc has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Blenrep for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide.
An approval decision by the European Commission is expected in the third quarter of 2025.
The CHMP opinion follows the approval of Blenrep combinations by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April and Japan’s Ministry of Health, Labour and Welfare earlier this month.
Superior efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support the CHMP opinion. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) versus a daratumumab-based triplet in DREAMM-7. The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.
DREAMM-7 and DREAMM-8 showed that any eye-related side effects associated with Blenrep can be managed and reversed with appropriate dose modifications and follow-up, allowing patients to maintain benefit and resulting in low rates of discontinuation (≤9%) in both trials.
Blenrep combinations are currently under review in all major markets globally, including in the US with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025, China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application), Canada, and Switzerland (with priority review for DREAMM-8).
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent 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.
In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:
