GSK has announced that the European Commission has granted approval for Blenrep (belantamab mafodotin) for treating adult patients with relapsed and refractory multiple myeloma. The drug is indicated as monotherapy in patients who have received at least four therapies; myeloma must be refractory to a minimum of one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and whose cancer progressed after the last therapy.
Blenrep is the first anti-BCMA (B-cell maturation antigen) therapy, which is indicated in patients whose cancer has been progressed even after treating with the current standard of care.
The approval for the drug is based on DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) trial. Blenrep was administered at a dose of 2.5 mg/kg every three weeks. The overall response rate was 32%, the median duration of response was 11 months, and overall survival was 13.7 months.
The most common side effects reported are keratopathy/microcyst-like epithelial changes, thrombocytopenia, anemia, blurred vision, nausea, pyrexia, infusion-related reactions, and lymphopenia.
Blenrep has a novel mechanism of action; the drug acts by targeting BCMA, a protein that is expressed on multiple myeloma cells.
The product has received the PRIME designation in Europe.
The product has received approval from the U.S. Food and Drug Administration earlier this month.
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