On April 20, 2026 , GlaxoSmithKline (GSK) announced that its drug Blenrep (generic name: belantamab mafodotin) had been approved by the National Medical Products Administration (NMPA) of China. The approved indication is for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) in combination with bortezomib and dexamethasone (BVd regimen) who have received at least one prior line of therapy .
This approval was based on the priority review process, and the combination therapy had previously been granted Breakthrough Therapy designation in China, both because it is expected to provide significant improvements over existing therapies.

Core approval information and key data
Approved regimen : Blenrep + bortezomib + dexamethasone (BVd).
Target patients : Adult patients with relapsed or refractory multiple myeloma who have previously received at least one first-line treatment.
Key advantages : 1) It is the first and only approved anti-BCMA (B-cell maturation antigen) therapy in China for the treatment of 2L+ multiple myeloma. 2) As the only approved anti-BCMA antibody-drug conjugate (ADC), it provides patients with a new and differentiated treatment option. 3) It is the only anti-BCMA therapy that can be administered entirely on an outpatient basis, requiring only a 30-minute intravenous infusion per dose, without the need for complex pre-treatment or hospitalization, greatly reducing the burden on patients and the healthcare system.
Key clinical data support this (from the DREAMM-7 Phase III trial).
This approval is primarily based on data from the pivotal Phase III clinical trial DREAMM-7. This trial was a multicenter, open-label, randomized study designed to evaluate the efficacy and safety of the BVd regimen compared to the daratumumab plus bortezomib plus dexamethasone (DVd) regimen in patients with relapsed/refractory multiple myeloma.
Experimental Design :
Patients were enrolled in a study of 494 patients with recurrent partial mitral disease (RRMM) who had received at least one prior line of therapy and whose disease had progressed during or after their most recent treatment. Patients were randomized 1:1 to receive either belantasumab (BVd) or diclofenac (DVd). Belantasumab (maffodil) was administered intravenously at a dose of 2.5 mg/kg every three weeks for the first eight cycles in combination with bortezomib and dexamethasone, followed by monotherapy. The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee. Secondary endpoints included overall survival (OS), duration of response (DOR), negative rate of minimal residual disease (MRD) assessed by next-generation sequencing, overall response rate (ORR), safety, and patient-reported quality of life outcomes.
Key findings :
Progression-free survival (PFS): The median PFS in the BVd group was nearly three times that in the DVd group (36.6 months vs. 13.4 months). The hazard ratio (HR) was 0.41 (95% CI: 0.31–0.53), p < 0.00001.
Overall survival (OS): At a median follow-up of 39.4 months, the BVd regimen demonstrated a statistically significant and clinically meaningful OS benefit. Compared with the DVd group, the BVd group reduced the risk of death by 42% (HR 0.58; 95% CI: 0.43–0.79; p = 0.00023). Three-year OS rate: 74% in the BVd group and 60% in the DVd group .
Broad patient benefit: The BVd regimen showed consistent benefit in subgroups of patients with poor prognosis, including those with high-risk cytogenetic features or those refractory to lenalidomide.
Safety: Ocular adverse reactions associated with Blenrep can be managed and reversed with appropriate dose adjustments and follow-up, resulting in a low rate of treatment discontinuation due to ocular adverse reactions (≤9%). In the BVd group, the most common (>30%) non-ocular adverse reactions were thrombocytopenia (87%) and diarrhea (32%) .
Regarding multiple myeloma and Blenrep
Disease burden : Multiple myeloma is the third most common blood cancer worldwide. In China, its incidence has doubled in the past thirty years, reaching approximately 30,000 new cases annually, and the mortality rate has increased by 50%.
Drug mechanism : Blenrep is an ADC drug that targets BCMA. It is composed of a humanized anti-BCMA monoclonal antibody conjugated to the cytotoxic drug monomethylaurestatin F (MMAF) via a non-cleavable linker.
Global Approval Status : Aside from China, Blenrep (in combination with different regimens) has been approved in multiple countries and regions, including the United States, the European Union, the United Kingdom, Japan, Canada, Switzerland, Brazil, and Australia, for the treatment of relapsed or refractory multiple myeloma at level 2L+. Review in other regions worldwide is still ongoing.

https://mp.weixin.qq.com/s/mT0-wziEDjnSxHtq0V3swQ