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GSK receives approval from UK MHRA for Blenrep combination

ALN

GSK PLC on Thursday said it has received authorisation from the UK Medicines & Healthcare products Regulatory Agency for Blenrep combinations in the treatment of adults with multiple myeloma.

The London-based pharmaceutical company said Blenrep, or belantamab mafodotin, was approved for the treatment of adult patients with multiple myeloma in combination with bortezomib plus dexamethasone, for patients who have received at least one prior therapy including lenalidomide.

This marks the first authorisation in the world for Blenrep in this treatment setting, GSK said.

The application was based on results from the Dreamm-7 and Dreamm-8 phase 3 trials in relapsed or refractory multiple myeloma, which demonstrated statistically significant progression-free survival results for Blenrep combinations versus usual standards of care.

Currently, the majority of patients with multiple myeloma relapse, and in the UK only 55% remain alive five years following diagnosis.

‘Today’s approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse. As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse,’ said Hesham Abdullah, senior vice president, global head oncology, R&D.

Shares in GSK closed down 1.7% at 1,323.14 pence in London on Thursday afternoon. The stock is down 17% over the past year.

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