By Fineline Cube 
GlaxoSmithKline (GSK, NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin‑blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.
Key Highlights
| Item | Detail |
|---|---|
| Approved Indication | 3L+ relapsed/refractory MM patients (≥2 prior PI + IMID) |
| Clinical Benefit | 51 % reduction in risk of death; median PFS 31.3 months vs 10.3 months with daratumumab‑based DVd |
| Safety Profile | Consistent with known profiles of Blenrep, bortezomib, and dexamethasone |
| Regulatory Milestone | First FDA approval of Blenrep in a lower‑line setting since 2020 |
Background on Blenrep
Blenrep is a targeted antibody‑drug conjugate (ADC) that binds B‑cell maturation antigen (BCMA) and delivers the cytotoxic auristatin F via a non‑cleavable linker. The technology was licensed from Seagen Inc. and Kyowa Kirin Group, enabling rapid clinical development.
- Initial U.S./EU Approval (2020) – 4L+ relapsed/refractory MM (anti‑CD38 + PI + IMID).
- Withdrawal (2022) – Due to the Phase III DREAMM‑3 study failing to hit its primary endpoint.
- Current Approval (2025) – Supported by the pivotal DREAMM‑7 Phase III trial, which demonstrated the robust survival benefit outlined above.
DREAMM‑7 Trial Snapshot
| Metric | Blenrep + BVd | Daratumumab + BVd (DVd) |
|---|---|---|
| Median PFS | 31.3 months | 10.3 months |
| Hazard Ratio (Death) | 0.49 (51 % reduction) | — |
| 3‑Year Overall Survival | 74.5 % | 59.2 % |
The study enrolled over 1,200 patients across 45 sites in North America, Europe, and Asia, providing a robust global evidence base.
Strategic Implications for GSK
- Portfolio Strengthening – Expands GSK’s high‑growth MM offering.
- Commercial Opportunity – Access to a sizable U.S. patient cohort (~45,000 annually) with unmet need.
- Future Development – GSK plans to explore earlier‑line combinations and synergy with next‑generation immunotherapies.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech