FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

GSK is seeking to reintroduce Blenrep (belantamab mafodotin) in the US following its previous market withdrawal after a confirmatory Phase III trial failed to meet requirements.45

Ahead of the FDA's Oncologic Drugs Advisory Committee (ODAC) meeting on July 17, 2025, the FDA flagged ongoing concerns about Blenrep's eye safety, notably ocular toxicity that had previously led to a boxed warning.25

The ODAC will deliberate whether Blenrep’s benefit-risk profile justifies its use in combination therapies for adults with relapsed or refractory multiple myeloma, specifically with bortezomib and dexamethasone, or pomalidomide and dexamethasone.4

GSK has described an 'appropriate plan' to manage eye-related side effects, including close monitoring of visual acuity and patient-reported outcomes.2

Blenrep recently won regulatory approvals in the UK and Japan for similar combination indications, reflecting new trial data showing positive efficacy and a manageable safety profile.13

The PDUFA target date for the FDA decision on Blenrep’s US return is July 23, 2025.4

Sources:

1. https://www.statnews.com/2025/04/17/gsk-blenrep-blood-cancer-uk-approval/

2. https://www.fiercepharma.com/pharma/eha-gsk-adds-fuel-adc-blenreps-comeback-case-new-pfs-data-ahead-potential-us-return

3. https://www.myeloma.org/blenrep-belantamab-mafodotin-blmf

4. https://www.bioworld.com/articles/722160-odac-meeting-nears-for-would-be-return-of-gsks-blenrep-in-mm

5. https://www.fiercepharma.com/pharma/gsk-eyes-blenreps-us-return-fda-flags-eye-safety-concerns-ahead-advisory-committee-meeting