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GSK's Marketing Authorization Application for Blenrep Combinations Accepted for Review in EU
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GSK's Marketing Authorization Application for Blenrep Combinations Accepted for Review in EU
Jul 19, 2024 4:25 AM

07:08 AM EDT, 07/19/2024 (MT Newswires) -- GSK (GSK) said Friday that the European Medicines Agency has accepted for review the marketing authorization application for Blenrep, in combination with bortezomib plus dexamethasone or pomalidomide plus dexamethasone, as a treatment for relapsed or refractory multiple myeloma.

The company said the application was based on interim results from two phase 3 trials that met primary endpoints and showed "statistically significant and clinically meaningful improvements" in progression-free survival.

The European Medicines Agency's Committee for Medicinal Products for Human Use is set to review the application and file a recommendation to the European Commission, said GSK.

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