GSK’s Blenrep returns to the US market after FDA approves resubmission
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The FDA has approved GSK’s Blenrep in combination with bortezomib and dexamethasone, clearing the drug’s return to the US market. The move ends a withdrawal that followed a failed confirmatory study and resets the catalyst timeline for investors and BD teams.
Blenrep FDA approval on Oct. 23, 2025 returns GSK’s BCMA antibody-drug conjugate to the U.S. market. The new label pairs belantamab mafodotin with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma after at least two prior lines.
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Key Takeaways
- FDA approved Blenrep + bortezomib + dexamethasone (BVd) on Oct. 23, 2025.
- Eligible adults need ≥2 prior lines including a proteasome inhibitor and an immunomodulatory agent.
- DREAMM-7 3L+ data: death-risk HR 0.49; median PFS 31.3 vs 10.4 months vs DVd (HR 0.31).
- Earlier accelerated monotherapy approval was withdrawn in 2022 after DREAMM-3.
What did the FDA approve this time?
FDA approved belantamab mafodotin-blmf (Blenrep) with bortezomib and dexamethasone for relapsed or refractory multiple myeloma after at least two prior lines, including a PI and an IMiD. The product is a BCMA-directed antibody and microtubule inhibitor conjugate.
FDA’s approval notice matches the Oct. 23, 2025 date and combination setting. See the FDA approval page.
How strong was the DREAMM-7 signal?
GSK said the approval rests on pivotal DREAMM-7. In patients with two or more prior lines including a PI and an IMiD, BVd cut the risk of death by 51% versus a daratumumab-based triplet (HR 0.49; 95% CI 0.32–0.76).
Median PFS tripled to 31.3 months (95% CI 23.5–NR) versus 10.4 months (95% CI 7.0–13.4) for DVd (HR 0.31; 95% CI 0.21–0.47). Safety was described as broadly consistent with the known profiles of the individual agents. Full company detail is on Business Wire and GSK’s U.S. release.
- Regimen: Blenrep + bortezomib + dexamethasone
- Line: ≥2 prior therapies (3L+ framing in subgroup)
- Comparator in cited subgroup: daratumumab + bortezomib + dexamethasone
Why is this a “return” rather than a first launch?
Blenrep first won accelerated approval in 2020 as monotherapy in heavily pretreated myeloma. After confirmatory DREAMM-3 failed to support conversion, GSK withdrew the U.S. product in 2022.
The 2025 Blenrep FDA approval is therefore a combination relaunch with a different evidence package and a REMS-oriented ocular safety program described in company materials. It is not a simple restoration of the old monotherapy label.
What should teams watch next?
GSK continues DREAMM follow-up, including overall survival updates expected in early 2028 for DREAMM-7 and DREAMM-8. DREAMM-10 is testing newly diagnosed transplant-ineligible patients.
Near-term commercial questions are REMS burden, eye-care logistics, and how BVd competes with other BCMA modalities already in clinics.
What remains unproven
Earlier-line benefit and long-term OS maturity are still unfolding. ODAC had raised benefit-risk concerns before the delayed 2025 decision; the approval does not erase monitoring needs for ocular toxicity.
For formulary committees, the decision point is the labeled 3L+ BVd population with DREAMM-7 effect sizes—not older monotherapy narratives.
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Frequently Asked Questions
What is the new Blenrep FDA approval?
On Oct. 23, 2025, FDA approved belantamab mafodotin-blmf with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma after at least two prior lines including a PI and an IMiD.
What DREAMM-7 data supported the return?
In the 3L+ subgroup, GSK reported a 51% reduction in risk of death (HR 0.49) and median PFS of 31.3 vs 10.4 months versus a daratumumab-based triplet (HR 0.31).
Why was Blenrep off the U.S. market before?
After 2020 accelerated approval, confirmatory DREAMM-3 did not support traditional conversion, and GSK withdrew U.S. marketing in 2022 before this 2025 combination approval.
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