Blenrep FDA Approval History
Blenrep (belantamab mafodotin-blmf) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.
- Blenrep is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- Blenrep is administered as an intravenous infusion over approximately 30 minutes once every 3 weeks.
- Blenrep is available only through a restricted program, called the Blenrep REMS.
- The Blenrep product label carries a boxed warning that advises the risk of ocular toxicity. Blenrep can cause changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.
- The most common adverse reactions include keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. The most common grade 3 or 4 laboratory abnormalities include platelets decreased, lymphocytes decreased, hemoglobin decreased, neutrophils decreased, creatinine increased, and gamma-glutamyl transferase increased.
Development Timeline for Blenrep
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