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GSK wins China approval for Blenrep for refractory multiple myeloma

ALN

GSK PLC on Monday said the National Medical Products Administration of China has approved Blenrep in combination with bortezomib and dexamethasone in the treatment of adults with relapsed or refractory multiple myeloma.

The London-based pharmaceuticals company said the approval is for those who have had at least one prior line of therapy

Multiple myeloma is the third most common blood cancer globally, noted GSK, with it generally considered treatable, but not curable. It said around 180,000 new cases are diagnosed each year.

GSK said the approval is supported by data from the Dreamm-7 phase three trial, and follows priority review of the application and breakthrough therapy designation for the combination that was based on its ‘potential to provide substantial improvement over available therapies’.

GSK noted that in the trial, the Blenrep combination showed a 42% reduction in risk of death and almost tripled progression-free survival versus a daratumumab-based triplet.

Shares in the company were down 0.2% at 2,140.00 pence during early trading on Monday in London.

‘Today’s approval of Blenrep brings anti-BCMA therapy to patients in China with relapsed or refractory multiple myeloma in 2L+, introducing a differentiated mechanism of action with the potential to help slow disease progression and extend survival,’ said Hesham Abdullah, senior vice president, Global Head Oncology, R&D at GSK.

‘Further, Blenrep as the only anti-BCMA ADC is fully outpatient administered, so patients can be treated at any site of care without complex pre-administration regimens or hospitalisation.’

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