GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) received approval from the FDA for use in combination with bortezomib and dexamethasone in adults with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent.
Blenrep is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate. Its efficacy was demonstrated in the DREAMM-7 clinical trial, a randomized, multicenter study in patients with relapsed or refractory multiple myeloma. The trial excluded patients previously treated with BCMA therapies or with existing significant corneal disease. Patients receiving the Blenrep-based regimen showed a median progression-free survival of 31.3 months, compared to 10.4 months in the comparator arm (hazard ratio 0.31), highlighting a significant improvement.
However, Blenrep’s approval comes with a boxed warning for ocular toxicity. In the DREAMM-7 trial, 92% of patients experienced some form of ocular toxicity, including severe cases requiring dose modifications in 83% of patients. As a result, Blenrep will be available only through a Risk Evaluation and Mitigation Strategy (REMS) program.
The recommended dose is 2.5 mg/kg every three weeks in combination for the first eight cycles, then as a single agent. Blenrep received orphan drug designation for this indication. Healthcare professionals are encouraged to report serious adverse events to FDA MedWatch.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!