The National Medical Products Administration (NMPA) of China has approved belantamab mafodotin (Blenrep) in combination with bortezomib (Velcade) and dexamethasone (Vd) for the treatment of adults with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy.1
The regulatory decision was supported by data from the phase 3 DREAMM-7 trial (NCT04246047), which showed that the belantamab mafodotin–based triplet yielded a median progression-free survival (PFS) of 36.6 months compared with 13.4 months for daratumumab (Darzalex) plus Vd (DVd; HR, 0.41; 95% CI, 0.31-0.53; P < .00001).
Furthermore, at a median follow-up of 39.4 months, belantamab vedotin plus Vd demonstrated a statistically significant and clinically meaningful 42% reduction in the risk of death compared with DVd (HR, 0.58; 95% CI, 0.43-0.79; P = .00023). The 3-year overall survival (OS) rates were 74% for patients treated with belantamab mafodotin plus Vd vs 60% for those who received DVd.
“[This] approval of [belantamab mafodotin] brings anti-BCMA therapy to patients in China with relapsed or refractory multiple myeloma in [second line or later], introducing a differentiated mechanism of action with the potential to help slow disease progression and extend survival,” Hesham Abdullah, senior vice president and global head of Oncology, R&D, at GSK stated in a news release. “Further, [belantamab mafodotin] as the only anti-BCMA antibody-drug conjugate is fully outpatient administered, so patients can be treated at any site of care without complex pre-administration regimens or hospitalization.”
In October 2025, the FDA approval belantamab mafodotin plus Vd for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.2 This decision was also backed by data from DREAMM-7.
Belantamab Mafodotin Combo Wins NMPA Approval for R/R Myeloma
- China’s NMPA approved belantamab mafodotin plus Vd for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy, following FDA approval for the combination in October 2025.
- In the phase 3 DREAMM-7 trial, belantamab mafodotin plus Vd nearly produced a median PFS of 36.6 months vs 13.4 months for DVd (HR, 0.41; 95% CI, 0.31-0.53; P < .00001).
- The belantamab mafodotin–based triplet demonstrated consistent benefit across difficult-to-treat subgroups, including those with high-risk cytogenetics and patients who were refractory to lenalidomide.
How was the DREAMM-7 trial conducted?
The multicenter, open-label, randomized phase 3 study enrolled 494 patients at least 18 years of age who had a confirmed diagnosis of multiple myeloma with documented disease progression during or after at least one prior line of therapy.1,3 Patients also needed an ECOG performance status of 0 to 2, adequate organ function, and measurable disease, defined by M-protein excretion levels, M-protein concentration, or serum free light chain levels; all prior treatment-related toxicities, excluding alopecia, had to be grade 1 or lower at the time of enrollment.3
Patients could not be refractory to daratumumab or any other anti-CD38 therapy, and those with prior exposure to any anti-BCMA therapy were not allowed to participate. Additional exclusion criteria included a history of allogenic stem cell transplant or ongoing grade 2 or higher peripheral neuropathy.
Participants were randomly assigned 1:1 to receive either Vd or DVd. In the experimental arm, belantamab mafodotin was given at 2.5 mg/kg every 3 weeks in combination with Vd for the first 8 cycles, followed by single-agent administration.1
PFS per an independent review committee assessment served as the trial’s primary end point.3 Key secondary end points include OS, duration of response, and minimal residual disease–negativity rate.
What was the safety profile of belantamab mafodotin plus Vd?
Safety data reflected the known profiles of the individual agents.1 The most common non-ocular adverse effects (AEs) reported for belantamab mafodotin plus Vd included thrombocytopenia (87%) and diarrhea (32%).
Ocular-related AEs were managed and reversed with appropriate dose modifications and follow-up. These toxicities led to a discontinuation rate of less than 9% in the experimental arm.
References
- Blenrep (belantamab mafodotin) approved in China for treatment of 2L+ relapsed/refractory multiple myeloma. News release. GSK. April 20, 2026. Accessed April 21, 2026. https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-approved-in-china-for-treatment-of-2lplus-relapsedrefractory-multiple-myeloma/
- FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma. FDA. October 23, 2025. Accessed April 21, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma
- Evaluation of efficacy and safety of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in participants with relapsed/refractory multiple myeloma (DREAMM 7). ClinicalTrials.gov. Updated October 24, 2024. Accessed April 21, 2026. https://clinicaltrials.gov/study/NCT04246047
