On 21 July 2016, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the medicinal product Onivyde (pegylated liposomal formulation of irinotecan), intended for the treatment of metastatic adenocarcinoma of the pancreas.
Onivyde contains irinotecan in a pegylated liposomal formulation.
When added to 5-fluorouracil (5-FU) 2,400 mg/m2 and leucovorin (LV) 400 mg/m2, Onivyde improved survival compared with 5-FU 2,000 mg/m2 and LV 200 mg/m2.
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