GSK Gains FDA Approval for Blenrep in Relapsed or Refractory Multiple Myeloma After DREAMM-7 Data

GlaxoSmithKline's re-entry into the BCMA-directed therapy space carries immediate compliance obligations for dispensing sites and ADC manufacturers: the FDA's October 23, 2025 approval of belantamab mafodotin-blmf (Blenrep) reinstates controlled distribution under the BLENREP REMS, requiring ophthalmologic monitoring protocols before each dose cycle.

The approval covers Blenrep in combination with bortezomib and dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Efficacy data from the open-label, randomized DREAMM-7 trial (NCT04246047) drove the submission, with a median progression-free survival of 31.3 months in the BVd arm versus 10.4 months in the daratumumab, bortezomib, and dexamethasone arm (HR 0.31; 95% CI: 0.21, 0.47). Median overall survival was not reached in the BVd arm versus 35.7 months in the comparator arm (HR 0.49; 95% CI: 0.32, 0.76).

The ocular toxicity profile is the central operational constraint. In DREAMM-7, ocular toxicity occurred in 92% of patients receiving belantamab mafodotin-blmf, with Grade 3 or 4 events in 77% and dosage modifications required in 83%. The Boxed Warning covers corneal epithelium changes resulting in vision deterioration, and the REMS program restricts dispensing to certified healthcare settings with documented ophthalmologic assessment workflows. QA leads at specialty pharmacy and hospital pharmacy sites will need to verify REMS certification and audit ophthalmology referral chains against program requirements before product is released to patients.

For manufacturing and supply chain functions, the approval signals sustained demand for antibody-drug conjugate production capacity. Belantamab mafodotin-blmf is a BCMA-directed ADC incorporating a microtubule inhibitor payload; its dosing schedule of 2.5 mg/kg every three weeks for eight combination cycles, followed by single-agent maintenance until progression, creates a predictable but technically demanding fill-finish and cold-chain profile. ADC manufacturing sites operating under 21 CFR Part 211 should anticipate heightened scrutiny of conjugation process controls and potent compound handling procedures as BCMA-directed ADC volume scales.

The prescribing information also lists thrombocytopenia and embryo-fetal toxicity under Warnings and Precautions, and the review incorporated GSK's voluntary Assessment Aid submission to support FDA's evaluation. Blenrep carries orphan drug designation. Additional warnings and dosing instructions for combination agents are detailed in the full prescribing information, to be posted on Drugs@FDA.

Regulatory affairs teams managing post-approval commitments should map REMS audit timelines against the first commercial distribution window, as BLENREP REMS compliance will be a leading indicator in any subsequent FDA inspection of certified dispensing sites.

Source: FDA Oncology Center of Excellence via FDA.gov Drugs RSS Feed, November 7, 2026.