Posted by Michael Wonder on 19 Oct 2016
Shire granted EU marketing authorisation of Onivyde, in combination with 5-fluorouracil and leucovorin, for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine-based therapy
18 October 2016 - Onivyde in combination with 5-fluorouracil and leucovorin, is the first and only treatment approved for this patient population based on pivotal Phase 3 data (NAPOLI-1) showing increased overall survival.
Shire announced that the European Commission has granted Marketing Authorisation of Onivyde (pegylated liposomal irinotecan hydrochloride trihydrate), also known as nal-IRI or MM-398, for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin, in adult patients who have progressed following gemcitabine-based therapy. Onivyde is the first and only approved treatment option for this patient population.
With this approval, Shire is authorized to market Onivyde in the 28 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. Onivyde was previously approved in the U.S. by the FDA in October 2015.
