LONDON - GSK plc (LSE/NYSE: GSK) announced Monday that the National Medical (TASE:PMCN) Products Administration (NMPA) of China has accepted the new drug application for Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone for priority review. This treatment is aimed at patients with relapsed or refractory multiple myeloma, a condition which has seen rising cases in China.
The submission is supported by phase III DREAMM-7 trial results, which demonstrated a statistically significant improvement in overall survival for patients treated with the Blenrep combination compared to the current standard of care. The trial met its primary endpoint by showing a clinically meaningful improvement in progression-free survival (PFS).
This marks the seventh major regulatory filing acceptance in 2024 for belantamab mafodotin combinations based on the DREAMM-7 and DREAMM-8 trials, with previous acceptances for review in the US, European Union, Japan, United Kingdom (TADAWUL:4280), Canada, and Switzerland.
Multiple myeloma is the third most common blood cancer globally, and while treatable, is not considered curable. In China, the disease has doubled in incidence and mortality has increased over the last thirty years. The Blenrep combination could potentially offer a new treatment option for patients at first relapse, addressing a significant unmet medical need.
The DREAMM-7 trial compared the efficacy and safety of the Blenrep combination against daratumumab plus bortezomib and dexamethasone in patients who had previously undergone at least one line of therapy. The trial's key secondary endpoint was overall survival, where the Blenrep combination showed a significant reduction in the risk of death.
Blenrep is an antibody-drug conjugate that targets the B-cell maturation antigen on the surface of myeloma cells. It is already approved as monotherapy in Hong Kong, and the current review in China is part of GSK's broader effort to expand its oncology portfolio, focusing on haematologic malignancies and other cancers.
The acceptance of this application by the NMPA is based on the interim results of the DREAMM-7 trial, and the information is derived from a press release statement by GSK.
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