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EU Fast-Track Loss For GSK's Dostarlimab

 
• By Maureen Kenny

GSK’s potential endometrial cancer treatment dostarlimab is one of two products to revert to standard review timelines in recent weeks.

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The EMA now wants more time to review the MAA for dostarlimab • Source: Shutterstock

GlaxoSmithKline plc’s dostarlimab has lost its accelerated assessment status at the European Medicines Agency. The marketing authorization application for endometrial cancer will now be reviewed under standard timelines.

Dostarlimab is under development for the treatment of patients with recurrent or advanced mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) endometrial cancer. The EMA’s drug evaluation committee, the CHMP, granted the investigational...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
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