EMA backs GSK’s Blenrep for multiple myeloma

NETHERLANDS – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of GSK’s Blenrep (belantamab mafodotin) for adults with relapsed or refractory multiple myeloma (MM).

This recommendation supports using Blenrep in combination with either bortezomib and dexamethasone (BVd) or pomalidomide and dexamethasone (BPd) for patients who have received at least one prior therapy.

The European Commission’s final decision is expected by the third quarter of this year. This follows recent regulatory approvals of Blenrep combinations in both the UK and Japan, strengthening its global momentum as a treatment option for multiple myeloma patients.

Blenrep is an antibody-drug conjugate (ADC) that targets cancer cells while limiting damage to healthy tissue.

Results from the pivotal Phase III DREAMM-7 and DREAMM-8 trials showed that Blenrep combinations delivered significant benefits in progression-free survival (PFS) and overall survival (OS), offering new hope for patients with few remaining treatment options.

The studies also showed that the safety and tolerability of the Blenrep combinations were consistent with the known side effects of the individual drugs.

Eye-related side effects, which are known risks with Blenrep, were found to be manageable and reversible through dose adjustments. Importantly, these side effects led to very few patients discontinuing treatment.

Blenrep is currently under regulatory review in several global markets, including the United States, where a Prescription Drug User Fee Act (PDUFA) decision is due on July 23, 2025.

The drug has also been granted breakthrough therapy status in China and is being reviewed under priority pathways in Canada and Switzerland.

According to Hesham Abdullah, GSK’s Global Head of Oncology R&D, Blenrep is designed to meet unmet needs in multiple myeloma while offering the advantage of convenient in-office administration without the need for complex pre-treatment or hospital stays.

Meanwhile, GSK continues to expand its pipeline, recently signing a deal worth up to US $2 billion to acquire efimosfermin from Boston Pharmaceuticals. The new drug is set to enter Phase III trials for the treatment of liver disease.