GSK plc (LON:GSK, NYSE: GSK) has announced the National Medical Products Administration (NMPA) of China has approved Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
· Blenrep combination showed a 42% reduction in risk of death and nearly tripled median progression-free survival versus a daratumumab-based triplet[1],[2]
· As the only anti-BCMA approved in 2L+ multiple myeloma in China, Blenrep provides a new and needed mechanism of action in therapy1,[3]
· Blenrep is the only fully outpatient anti-BCMA therapy, minimising patient and healthcare burden[4]
The approval follows priority review[5] of the application and Breakthrough Therapy Designation[6] for the BVd combination based on its potential to provide substantial improvement over available therapies.[7]
The Blenrep approval is supported by data from the pivotal DREAMM-7 phase III trial. These include statistically significant and clinically meaningful progression-free survival (PFS) and overall survival (OS) results for the Blenrep combination versus a daratumumab-based triplet combination with bortezomib and dexamethasone (DVd). The safety and tolerability profiles of the Blenrep combination were broadly consistent with the known profiles of the individual agents.1,2
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Patients with multiple myeloma who face relapse need treatment options that are both effective and accessible. Today’s approval of Blenrep brings anti-BCMA therapy to patients in China with relapsed or refractory multiple myeloma in 2L+, introducing a differentiated mechanism of action with the potential to help slow disease progression and extend survival. Further, Blenrep as the only anti-BCMA ADC is fully outpatient administered, so patients can be treated at any site of care without complex pre-administration regimens or hospitalisation.”
In China, the incidence of multiple myeloma has doubled to approximately 30,000 new cases annually and mortality has increased by 50% over the past three decades.[8] Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, which provides patients with a differentiated mechanism of action. Blenrep can be administered to a range of patient types across treatment settings as a 30-minute outpatient infusion.
[1] Hungria V, Robak P, Hus M et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. PMID: 38828933.
[2] Hungria V, Robak P, H Marek, et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and Updated Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. December 2024.
[3] Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20). doi:10.1182/blood-2014-11-568923.
[4] Blenrep US Prescribing Information.
[5] GSK press release issued 9 December 2024. Blenrep (belantamab mafodotin) combination accepted for priority review in China in relapsed/refractory multiple myeloma. Available at: https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/.
[6] GSK press release issued 13 September 2024. Blenrep (belantamab mafodotin) in combination receives Breakthrough Therapy Designation in China for treatment of relapsed/refractory multiple myeloma. Available at: https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-in-combination-receives-breakthrough-therapy-designation-in-china-for-treatment-of-relapsedrefractory-multiple-myeloma/.
[7] China Drug Registration Regulation. Available at: http://www.gov.cn/gongbao/content/2020/content_5512563.htm. Accessed 16 March 2026.
[8] Liu J, Liu W, Mi L, et al. Burden of multiple myeloma in China: an analysis of the Global Burden of Disease, Injuries, and Risk Factors Study 2019. Chin Med J (Engl). 2023;136(23):2834-2838. Published 2023 Dec 5. doi:10.1097/CM9.0000000000002600.
