CHMP of the European Medicines Agency Recommends Approval of Blenrep

May 23, 2025—According to a press release from GSK, "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."

The results from the pivotal phase III DREAMM-7 and DREAMM-8 trials support the CHMP’s positive opinion on Blenrep combinations for relapsed or refractory multiple myeloma. In both trials, Blenrep combinations showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to standard treatments. In DREAMM-7, they also showed a survival benefit over a daratumumab-based triplet. The safety and tolerability of the Blenrep combinations were generally in line with what is already known about the individual drugs.

Read the full press release from the button below.