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GSK: Please, EMA, Can We Have Some More?

Company Is Seeking Another Speedy Review

 
• By Neena Brizmohun and Maureen Kenny

Hot on the heels of winning EU fast-track review status for belantamab mafodotin, GlaxoSmithKline has asked the European Medicines Agency to grant accelerated assessment to another of its planned marketing applications.

View from Side of Car moving in a night city, Blured road with lights with car on high speed. Concept rapid rhythm of a modern city.
GSK wants the EMA to speed up its review of dostarlimab • Source: Shutterstock

GlaxoSmithKline should soon learn whether the European Medicines Agency will agree to fast-track its planned EU marketing application for dostarlimab, the investigational PD-1 inhibitor for treating endometrial cancer that the company recently filed for approval in the US. The company very recently won EMA fast-track status for its multiple myeloma candidate, belantamab mafodotin.

GSK’s request for accelerated assessment for dostarlimab in Europe is listed on the agenda of the latest monthly meeting of the EMA’s drug evaluation committee, the CHMP, which is...

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