GSK plc has announced that China’s National Medical Products Administration (NMPA) has approved Blenrep in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory Multiple Myeloma who have received at least one prior therapy. The approval was granted under priority review and follows the drug’s Breakthrough Therapy Designation, highlighting its potential to significantly improve treatment outcomes.

The decision is supported by results from the pivotal DREAMM-7 phase III clinical trial, which demonstrated statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) compared to a daratumumab-based regimen. Patients receiving the Blenrep combination experienced nearly three times longer median PFS and a substantial reduction in the risk of death.

Blenrep is an antibody-drug conjugate targeting B-cell maturation antigen (BCMA), offering a differentiated mechanism of action in treating multiple myeloma. It is administered as a short outpatient infusion, enabling broader accessibility across treatment settings without the need for complex hospital-based procedures.

Multiple myeloma remains a significant health burden globally, with around 180,000 new cases diagnosed annually. In China, incidence rates have risen sharply in recent decades, underlining the need for more effective and accessible therapies. While treatable, the disease is typically not curable and often becomes resistant to existing treatments over time.

Clinical data from DREAMM-7 showed that the Blenrep-based regimen improved survival outcomes across a wide range of patient groups, including those with high-risk disease features. The therapy also demonstrated manageable safety and tolerability, with side effects such as thrombocytopenia and diarrhoea being the most commonly reported.

The approval marks another milestone in expanding treatment options for patients with relapsed or refractory multiple myeloma in China, reinforcing the role of innovative therapies in improving long-term outcomes and quality of life.