GSK PLC on Friday announced that it has been granted breakthrough therapy designation in China for Blenrep, a treatment for relapsed or refractory multiple myeloma.
The London-based pharmaceuticals company said that the Centre for Drug Evaluation for the National Medical Products Administration in China granted the designation for Blenrep combined with bortezomib plus dexamethasone.
Multiple myeloma is the third most common blood cancer globally and, though considered treatable, it is not currently curable. There are approximately 30,000 new cases of the condition each year in China, with its incidence having doubled in the last 30 years.
The breakthrough therapy designation enables therapy development to be expedited for serious and life-threatening diseases for which there are no existing treatments, or where evidence has shown an improvement in patient outcomes over existing treatment options.
It was granted based on the interim results of the phase III head-to-head DREAMM-7 trial, which met its primary goal of showing statistically significant and clinically meaningful improvements in progression-free survival for belantamab mafodotin combined with BorDex compared to daratumumab plus BorDex in relapsed or refractory multiple myeloma.
Senior Vice President & Global Head Oncology, R&D Hesham Abdullah said: ‘Breakthrough therapy designation in China underscores the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after their first relapse. We look forward to continuing to work with the health authority in China and others worldwide to bring Blenrep-based combinations to patients as expeditiously as possible.’
Shares in GSK were down 0.6% at 1,628.79 pence each in London on Friday morning.
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