GSK's Blenrep receives Breakthrough Therapy Designation in China for myeloma

GSK plc's cancer drug Blenrep (belantamab mafodotin) has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Administration (NMPA). The designation applies to Blenrep when used in combination with bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma.

The BTD was awarded by the Center for Drug Evaluation (CDE) based on interim results from the Phase III DREAMM-7 trial. This head-to-head study showed that the combination of Blenrep with bortezomib and dexamethasone achieved statistically significant and clinically meaningful improvements in progression-free survival compared to the current standard of care combination.

Multiple myeloma is a growing health concern in China, with approximately 30,000 new cases annually. The disease's incidence has doubled and mortality has increased by 50% over the last three decades, highlighting the need for novel and effective treatment options, particularly for patients whose disease has progressed or become resistant to existing therapies.

The Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious conditions where preliminary evidence indicates potential for substantial improvement over available treatments. GSK stated it looks forward to working with Chinese health authorities to bring Blenrep-based combinations to patients as quickly as possible.