LONDON (dpa-AFX) - Friday, GSK plc (GSK) announced that the European Medicines Agency has accepted the marketing authorization application or MAA for Blenrep in combination with bortezomib plus dexamethasone or BorDex, or pomalidomide plus dexamethasone, for treating relapsed or refractory multiple myeloma.
The biopharma company stated that this application is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, both of which met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival for the Blenrep combinations compared to standard care.
The European Medicines Agency's Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission regarding this potential authorization.
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