The FDA has reapproved GlaxoSmithKline’s belantamab mafodotin-blmf as of Oct. 23 for adults with relapsed or refractory multiple myeloma — three years after the drug was voluntarily withdrawn from the market due to unsuccessful trial results.
The B-cell maturation antigen-directed therapy was first granted accelerated approval in 2020 but pulled in 2022 after a confirmatory trial failed to meet its endpoint. The new approval covers use in combination with bortezomib and dexamethasone for patients who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, according to a news release from the FDA.
Approval was based on a trial in which the combination regimen improved median progression-free survival to 31.3 months, compared with 10.4 months for the control arm. Median overall survival was not reached in the treatment group and was 35.7 months in the comparator group.
Ocular toxicity occurred in 92% of patients receiving the drug, including 77% with Grade 3 or 4 events. The FDA included a boxed warning and restricted access to the drug through a risk evaluation and mitigation strategy program.
The reapproval came in the wake of regulatory scrutiny. In July, the FDA’s Oncologic Drugs Advisory Committee raised concerns about safety and dosing schedules after reviewing phase 3 trial data. The panel ultimately voted against approval for broader indications, citing the drug’s toxicity profile.
