GSK PLC on Friday said its treatment for relapsed or refractory multiple myeloma has been accepted for review by a European regulatory panel.
A drug combination that includes GSK’s Blenrep, whose generic name is belantamab mafodotin, was accepted for review by the European Medicines Agency’s Committee for Medicinal Products for Human Use. The review process will lead to a recommendation to the European Commission for marketing authorisation.
Multiple myeloma is a cancer in a type of white blood cell.
GSK said the submission to the EMA was supported by the phase III head-to-head Dreamm-7 and Dreamm-8 trials, which showed significant progression-free survival benefit and positive overall survival trends for Blenrep combinations versus standard of care.
‘Today’s milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse,’ said Hesham Abdullah, global head of Oncology, R&D, at GSK. ‘We are working to bring Blenrep to patients as quickly as possible given the high unmet need.’
GSK shares were down 0.9% to 1,516.50 pence early Friday in London.
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