R/R MM: benefit of belantamab outweighs ocular risk

  • FDA
  • 14 Jul 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • Despite concerns over ocular toxicity, the US Food and Drug Administration (FDA) advisory panel has given a thumbs-up to belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma (R/R MM), taking it a step closer to approval.

Key highlights

  • The FDA panel sought expert feedback on the manufacturer's application for belantamab's accelerated approval, primarily based on a phase 2 study.
  • The FDA's Oncologic Drugs Advisory Committee voted 12-0 in favor of belantamab's benefit-risk ratio, despite some concerns regarding ocular toxicity with belantamab.
  • In the phase 2 DREAMM-2 trial, the overall response rate was 31% in the cohort (n=97) that received a 2.5 mg/kg dose.
  • The other cohort (n=99), which received a 3.4 mg/kg dose, had a less favorable safety profile; however, the incidence of ocular toxicities was comparable for the 2 doses.
  • At least 1 episode of severe keratopathy was recorded, and some patients had ocular side effects resulting in severe vision loss that interfered with their routine activities such as driving and reading.
  • Addressing the concerns over ocular toxicities, the manufacturer has proposed a risk evaluation and mitigation strategy for detection and treatment of potential complications.
  • The FDA panelists seemed confident that the potential ocular risk could be managed.
  • They also recommend educating prescribers and patients about these risks.