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# Ocular Toxicity Concerns with Multiple Myeloma Drug: FDA
- URL: https://www.fdaweb.com/ocular-toxicity-concerns-with-multiple-myeloma-drug-fda/
- Published: 2025-07-15T12:00:00.000Z
- Updated: 2026-09-14T15:16:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159504

FDA reviewers are weighing concerns about ocular toxicity seen in trial data submitted by GSK in its BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma in combination with other therapies in patients who have received at least one prior line of therapy. Blenrep was originally granted accelerated approval in 2020 for heavily pretreated multiple myeloma patients. In 2022, its approval was withdrawn after the DREAMM-3 trial, designed to confirm the drug’s benefit, did not demonstrate superiority over standard treatment.

The agency is convening a 7/17 Oncologic Drugs Advisory Committee meeting to evaluate whether belantamab mafodotin has a safe and appropriate dosing schedule in light of new Phase 3 data from the DREAMM-7 and DREAMM-8 studies, and ongoing concerns about severe ocular side effects.

An FDA [briefing document](https://www.fda.gov/media/187578/download?ref=fdaweb.com) says the new data show that belantamab mafodotin, when combined with standard therapies, significantly improved progression-free survival compared to comparator regimens. Despite the positive efficacy data, agency reviewers say both trials highlighted a persistent and troubling safety signal — ocular toxicity. Between 77% and 78% of patients in the belantamab-containing arms experienced Grade 3 or 4 eye-related adverse events, including keratopathy, vision changes, dry eyes, and photophobia. These toxicities also led to high treatment interruption rates — up to 94% in DREAMM-7 — and were compounded by poor overall tolerability, with nearly all patients experiencing some form of severe treatment-emergent adverse event, they say.

The reviewers note that these safety concerns raise “uncertainty regarding the appropriateness of the proposed dosages,” even though different dosing strategies were used in the two trials to try to mitigate toxicity. The advisory committee will be asked to weigh whether a safe and effective dosing regimen for belantamab mafodotin has been adequately established. Their decision could determine whether the drug is re-approved under full approval terms for earlier use in multiple myeloma patients.