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Blenrep FDA Approval History

FDA Approved: Yes (First approved August 5, 2020)
Brand name: Blenrep
Generic name: belantamab mafodotin-blmf
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: Multiple Myeloma

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

DateArticle
Aug  5, 2020Approval FDA Approves Blenrep (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Jun 19, 2020GSK Announces FDA Advisory Committee Meeting to Review Belantamab Mafodotin for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
Jun  4, 2020GSK Announces New Data Presentations from the DREAMM Programme Exploring Investigational Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma
May 27, 2020DREAMM-2 and DREAMM-6 Data at ASCO Reinforce the Potential of GSK’s Investigational Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma
Jan 27, 2020FDA Grants Priority Review of Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma
Dec 16, 2019Pivotal DREAMM-2 Study Demonstrated a Clinically Meaningful Overall Response Rate with Belantamab Mafodotin (GSK2857916) for Patients with Relapsed/Refractory Multiple Myeloma
Aug 23, 2019GSK Announces Positive Headline Results from the Pivotal DREAMM-2 Study for Multiple Myeloma

Further information

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