FDA Approves GSK's ADC Blenrep with Over 50% Reduction in Death Risk for Relapsed/Refractory Multiple Myeloma

(Source:WuXi AppTec）

Source: WuXi AppTec

GSK announced today that the U.S. FDA has approved its antibody-drug conjugate (ADC) Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies.Meanwhile, GSK is actively advancing the clinical development of Blenrep, aiming to expand its application to earlier treatment lines, including for newly diagnosed patients.

The approval of Blenrep is based on data from the pivotal Phase 3 clinical trial DREAMM-7. In the study, patients were randomly assigned in a 1:1 ratio to receive either Blenrep, bortezomib, and dexamethasone or daratumumab, bortezomib, and dexamethasone (DVd). The efficacy evaluable population included 217 patients (108 in one group and 109 in the other), all of whom had received at least two prior treatment regimens, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMID).

Analysis shows that the Blenrep combination regimen demonstrated clinically significant benefits compared to the active control group:The risk of patient death was reduced by 51% (HR=0.49, 95% CI: 0.32–0.76). The median progression-free survival (PFS) in the Blenrep combination therapy group was extended to 31.3 months (95% CI: 23.5–not yet reached [NR]), compared to 10.4 months (95% CI: 7.0–13.4) in the active control group., with a hazard ratio of 0.31 (95% CI: 0.21–0.47). In terms of median overall survival (OS), the Blenrep combination therapy group and the active control group were NR and 35.7 months (95% CI: 21.1–NR), respectively, with a hazard ratio of 0.49 (95% CI: 0.32–0.76).

The safety and tolerability of Blenrep in combination regimens are generally consistent with the known profiles of each individual drug.

Blenrep is an ADC targeting B-cell maturation antigen (BCMA)., composed of a humanized anti-BCMA monoclonal antibody and the cytotoxic drug auristatin F (auristatin F) conjugated via a non-cleavable linker, which can eliminate myeloma cells through multiple mechanisms of action.

References:

[1] Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma. Retrieved October 23, 2025 from https://www.gsk.com/media/ddwl01jr/blenrep-fda-release_final-to-be-issued.pdf

[2] FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma. Retrieved October 23, 2025 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma