Blenrep FDA approval returns in R/R myeloma
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GSK’s Blenrep has returned to the U.S. market after the FDA approved it in combination with bortezomib and dexamethasone for relapsed or refractory multiple myeloma. The catalyst matters for BD teams and investors because it reverses a prior withdrawal and resets the drug’s U.S. label and commercial outlook.
The October 23, 2025 Blenrep FDA approval puts GSK’s BCMA antibody-drug conjugate back on the U.S. label with bortezomib and dexamethasone for relapsed or refractory multiple myeloma after at least two prior lines. DREAMM-7 progression-free survival nearly triples the daratumumab triplet comparator in the labeled subgroup.
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Key Takeaways
- FDA approved Blenrep (belantamab mafodotin-blmf) with bortezomib and dexamethasone on October 23, 2025.
- Labeled population: adults with R/R myeloma after ≥2 prior lines including a PI and an IMID.
- DREAMM-7 (NCT04246047): median PFS 31.3 vs 10.4 months (HR 0.31); OS HR 0.49.
- Boxed Warning for ocular toxicity; ocular events in 92% of Blenrep patients in DREAMM-7.
What did the Blenrep FDA approval cover?
The FDA approved belantamab mafodotin-blmf with bortezomib and dexamethasone 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.
Primary notice: FDA Blenrep approval page. GSK’s U.S. release matches the same labeled population.
How strong were DREAMM-7 efficacy results?
Efficacy came from DREAMM-7, an open-label, randomized, multicenter Phase 3 trial. In the efficacy population of 217 patients with ≥2 prior lines including a PI and IMID, median PFS was 31.3 months (95% CI 23.5–NR) for BVd versus 10.4 months (95% CI 7–13.4) for DVd (HR 0.31; 95% CI 0.21–0.47).
Median OS was not reached versus 35.7 months (HR 0.49; 95% CI 0.32–0.76). Trial ID: NCT04246047.
Why the ocular safety program matters
The FDA highlights a Boxed Warning for ocular toxicity, including corneal epithelium changes that can deteriorate vision. Among patients receiving belantamab mafodotin-blmf in DREAMM-7, ocular toxicity occurred in 92%, including Grade 3 or higher events detailed on the FDA page and label.
- Mechanism: BCMA-directed antibody–microtubule inhibitor conjugate
- Comparator in DREAMM-7: daratumumab + bortezomib + dexamethasone
- Prior BCMA therapy: excluded from DREAMM-7
- Label reference: DailyMed BLENREP
What GSK said about the commercial return
GSK framed the decision as a U.S. return for Blenrep in 3L+ myeloma after the 2022 withdrawal era. Company materials emphasize the 51% reduction in risk of death and tripled median PFS versus the daratumumab triplet in the 3L+ subgroup.
Source: GSK U.S. Blenrep approval release.
What remains unproven
Approval in ≥2 prior lines does not prove benefit in newly diagnosed or single-prior-line settings. Longer OS follow-up and earlier-line DREAMM studies are still maturing. Real-world ocular monitoring burden may limit uptake even with strong PFS.
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Frequently Asked Questions
When did the FDA reapprove Blenrep?
On October 23, 2025, the FDA approved belantamab mafodotin-blmf (Blenrep, GSK) with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma after at least two prior lines including a proteasome inhibitor and an immunomodulatory agent.
What DREAMM-7 results supported Blenrep FDA approval?
In the labeled efficacy population, median PFS was 31.3 months with BVd versus 10.4 months with DVd (HR 0.31). Median OS was not reached versus 35.7 months (HR 0.49). The trial is NCT04246047.
What safety warning accompanies Blenrep?
Blenrep carries a Boxed Warning for ocular toxicity, including corneal epithelium changes that can worsen vision. In DREAMM-7, ocular toxicity occurred in 92% of patients receiving belantamab mafodotin-blmf. Use is tied to risk-mitigation requirements.
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