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EMA Recommends Stemline’s Elzonris After Initial Rejection

 
• By Neena Brizmohun

While the European Medicine Agency now recommends that Elzonris should be approved in the EU, Stemline Therapeutics will have to submit the results of a study based on a registry of patients with blastic plasmacytoid dendritic cell neoplasm.

man hand touching button and ticking check box. check boxes cloud.
Elzonris has taken a step closer to the EU market • Source: Shutterstock

The European Medicines Agency has revisited its rejection of Elzonris (tagraxofusp), and now says that Stemline Therapeutics’ drug for treating blastic plasmacytoid dendritic cell neoplasm (BPDCN) should be granted EU marketing approval, albeit under certain conditions.

The recommendation follows the agency’s re-examination of its initial opinion in July that the drug should not be approved for...

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