Belantamab Mafodotin Combo for R/R Multiple Myeloma Earns Approval in China

China’s National Medical Products Administration has approved belantamab mafodotin (Blenrep) plus bortezomib (Velcade) and dexamethasone (BVd) as a treatment for adult patients with relapsed/refractory multiple myeloma following 1 or more prior lines of treatment, according to a press release from the developer, GSK.¹

The approval was based on data from the phase 3 DREAMM-7 trial (NCT04246047) assessing BVd vs daratumumab (Darzalex) plus bortezomib/dexamethasone (DVd) among patients with relapsed/refractory multiple myeloma. Prior data revealed a median progression-free survival (PFS) of 36.6 months with BVd and 13.4 months with DVd (HR, 0.41; 95% CI, 0.31-0.53; P <.00001). Belantamab mafodotin-based treatment also significantly improved overall survival (OS) compared with DVd after a median follow-up of 39.4 months (HR, 0.58; 95% CI, 0.43-0.79; P = .00023). The OS rates at 3 years were 74% vs 60%, respectively.

Findings from DREAMM-7 showed consistent benefits with BVd across patients with poor prognostic features or outcomes, including those with high-risk cytogenetics or refractory disease following treatment with lenalidomide (Revlimid). Additionally, eye-related adverse effects (AEs) with belantamab mafodotin appeared to be manageable and reversible with appropriate dose modifications and follow up. The most common non-ocular toxicities with BVd included thrombocytopenia (87%) and diarrhea (32%).

“Patients with multiple myeloma who [experience] relapse need treatment options that are both effective and accessible. Today’s approval of [belantamab mafodotin] brings anti-BCMA therapy to patients in China with relapsed or refractory multiple myeloma in [the second line and beyond], 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 Research & Development at GSK, stated in the press release.¹ “Further, [belantamab mafodotin] as the only anti-BCMA antibody drug conjugate [ADC] is fully outpatient administered, so patients can be treated at any site of care without complex pre-administration regimens or hospitalization.”

In the open-label, multicenter DREAMM-7 trial, 494 patients with documented disease progression or on after their most recent line of therapy for multiple myeloma were randomly assigned 1:1 to receive BVd or DVd. In the experimental arm, patients received belantamab mafodotin at 2.5 mg/kg intravenously every 3 weeks as part of a combination regimen for the first 8 cycles followed by monotherapy.

The trial’s primary end point was PFS based on independent review committee assessment. Secondary end points included OS, duration of response, minimal residual disease negativity per next-generation sequencing, overall response rate, safety, and patient-reported outcomes.

Patients 18 years and older with a confirmed diagnosis per International Myeloma Working Group criteria, documented disease progression after at least 1 prior line of treatment for multiple myeloma, an ECOG performance status of 0 to 2, and adequate organ function were eligible for enrollment on the trial.² Those with intolerance of daratumumab, ongoing grade 2 or higher peripheral neuropathy or neuropathic pain, or prior treatment with anti-BCMA agents were ineligible for study entry. Having prior allogeneic stem cell transplant or corneal epithelial disease were also grounds for exclusion from the trial.

The FDA approved belantamab mafodotin in combination with bortezomib and dexamethasone for patients with multiple myeloma and 2 or more prior lines of treatment in October 2025.³ The agency based its decision on data from the DREAMM-7 trial.

“With the approval of [belantamab mafodotin], we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following 2 or more prior lines of treatment, where options are limited. This approval marks an important advance in the US relapsed/refractory treatment landscape,” Sagar Lonial, MD, FACP, FASCO, said in a press release at the time of the FDA approval.³ Lonial is a professor and chair of the Department of Hematology and Medical Oncology and the Anne and Bernard Gray Family Chair in Cancer at Emory University School of Medicine and the chief medical officer at Winship Cancer Institute of Emory University. He is also a member of the International Myeloma Foundation scientific board.

References

1. Blenrep (belantamab mafodotin) approved in China for treatment of 2L+ relapsed/refractory multiple myeloma. News release. GSK. April 20, 2026. Accessed April 20, 2026. https://tinyurl.com/4sbfxz66
2. 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 20, 2026. https://tinyurl.com/yc5thzmb
3. Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma. News release. GSK. October 23, 2025. Accessed April 20, 2026. https://tinyurl.com/4fbwz9cu