Palantir a high-risk investment with ’a one-of-a-kind growth and margin model’
LONDON - GlaxoSmithKline plc (LSE/NYSE:GSK) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of Blenrep in combination therapies for adults with relapsed or refractory multiple myeloma. This endorsement, announced today, could lead to the European Commission’s approval in the third quarter of 2025.
Blenrep, in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd), has demonstrated superior efficacy in two phase III trials, DREAMM-7 and DREAMM-8. The trials showed statistically significant improvements in progression-free survival and, in the case of DREAMM-7, overall survival when compared to current standards of care. The safety profiles of these combinations were consistent with those of the individual drugs involved.
The positive CHMP opinion follows approvals by the UK Medicines and Healthcare products Regulatory Agency in April and by Japan’s Ministry of Health, Labour and Welfare earlier this month.
Europe sees about 50,000 new cases of multiple myeloma annually, with most patients eventually relapsing from initial treatments. Blenrep, an anti-BCMA (B-cell maturation antigen) antibody-drug conjugate, offers a new mechanism of action for patients post-first relapse and can be administered in various oncology treatment settings.
The DREAMM-7 trial nearly tripled median progression-free survival for BVd compared to a daratumumab-based triplet. Furthermore, DREAMM-7 met the key secondary endpoint of overall survival, showing a 42% reduction in the risk of death. DREAMM-8 also demonstrated a significant improvement in progression-free survival with BPd compared to an alternative regimen.
Eye-related side effects associated with Blenrep were manageable and reversible, with low discontinuation rates in both trials. The most common non-ocular adverse events included thrombocytopenia and diarrhea in DREAMM-7, and neutropenia, thrombocytopenia, and COVID-19 in DREAMM-8.
Blenrep combinations are under review in major markets globally, including the US, with a decision expected by July 23, 2025, and in China, Canada, and Switzerland, where the applications have been granted priority review.
This information is based on a press release statement from GSK.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.