GSK plc has announced that the European Union has approved its drug Blenrep (belantamab mafodotin) in combination therapies for the treatment of adults with relapsed or refractory multiple myeloma. The decision marks a significant milestone in multiple myeloma care, offering new treatment options for patients who have received at least one prior therapy.
Blenrep is now authorized for use in two combinations: with bortezomib and dexamethasone (BVd), and with pomalidomide and dexamethasone (BPd). The approvals are based on positive results from two pivotal Phase III clinical trials, DREAMM-7 and DREAMM-8, which demonstrated superior efficacy over standard-of-care triplet regimens, particularly in terms of progression-free survival (PFS) and overall survival (OS).
In the DREAMM-7 trial, the Blenrep combination nearly tripled median PFS compared to a daratumumab-based regimen (36.6 months vs. 13.4 months) and showed a 42% reduction in risk of death. The DREAMM-8 trial also showed significant PFS improvement compared to standard treatment, with the median PFS not yet reached at the time of analysis.
“Today’s approval is a redefining moment for patients in the EU,” said Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK. “With superior efficacy and the potential for outpatient administration, Blenrep combinations represent a fundamentally differentiated approach to multiple myeloma treatment.”
Blenrep is the only approved anti-BCMA (B-cell maturation antigen) antibody-drug conjugate for multiple myeloma, offering a novel mechanism of action that targets difficult-to-treat cases. The drug demonstrated benefits across a wide patient population, including those with high-risk features or refractory to previous treatments like lenalidomide.
Eye-related side effects, previously a concern with Blenrep, were manageable in both trials with dose adjustments and regular monitoring. Non-ocular side effects such as thrombocytopenia, neutropenia, and infections like COVID-19 were consistent with known profiles of the treatment components.
In addition to the EU, Blenrep combinations have already been approved in the UK, Japan, Canada, and Switzerland. Regulatory reviews are ongoing in the U.S., China, and other major markets, with the U.S. FDA granting Breakthrough Therapy Designation and priority review based on DREAMM-7 results.
With more than 50,000 new cases of multiple myeloma diagnosed annually in Europe, GSK’s expanded Blenrep approvals are expected to play a key role in improving outcomes for patients facing relapsed or refractory disease.