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China’s NMPA grants Breakthrough Therapy Designation for GSK’s Blenrep® in Combination with BorDex.

Sep 13, 2024

On 13 September 2024, Glaxo Smith Kline (GSK) announced that China’s National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) for its Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) for treatment for relapsed or refractory multiple myeloma.  NMPA BTD is intended to expedite the development of therapies for serious and life-threatening diseases where there are no existing treatments or where initial evidence has shown improvement in patient outcomes over existing treatments.

This news follows GSK’s announcement in February 2024 of results from an interim analysis of its DREAMM-7 phase III trial comparing Blenrep® in combination with BorDex with daratumumab in combination with BorDex.  The results showed a 59% further reduction in risk of disease progression or death, 23.2 more months of median progression-free survival, and a 43% reduction in risk of death.