Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) declared on Monday that it has received approval from China's National Medical Products Administration for Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The approval, granted following priority review and Breakthrough Therapy Designation, is supported by Phase III DREAMM-7 trial data, which demonstrated a statistically significant improvement in progression-free and overall survival versus a daratumumab-based triplet regimen. The Blenrep combination reduced the risk of death by 42% and nearly tripled median progression-free survival to 36.6 months, compared with 13.4 months for the comparator.
Blenrep is currently the only anti-BCMA therapy approved in the 2L+ setting in China and is delivered as a 30-minute outpatient infusion, offering a differentiated and accessible treatment option. The therapy showed a safety profile consistent with prior studies, with manageable adverse events.
The approval comes amid rising incidence and mortality rates for multiple myeloma in China, where approximately 30,000 new cases are diagnosed annually. Globally, the disease remains the third most common blood cancer, with around 180,000 new cases each year and limited curative options.
Blenrep has secured more than 15 regulatory approvals globally in relapsed or refractory multiple myeloma and remains under review in additional markets. GSK continues to advance its oncology pipeline, with a focus on antibody-drug conjugates and targeted therapies aimed at improving survival outcomes and quality of life.
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GSK secures China approval for Blenrep in relapsed multiple myeloma