STML - European advisory group backs Stemline's Elzonris for rare blood cancer

After re-examining its initial negative opinion issued in July, the European Medicines Agency's advisory group CHMP has reversed itself and now recommends approval of Stemline Therapeutics' (STML) Elzonris (tagraxofusp) for the treatment of a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm in a first-line setting.The initial application sought approval to treat these patients regardless of whether they had received previous therapies.A final decision from the European Commission usually takes ~60 days.Stemline was acquired by Menarini Group in June for up to $677M.

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European advisory group backs Stemline's Elzonris for rare blood cancer