EU approves Onivyde (pegylated liposomal irinotecan hydrochloride trihydrate) to treat adenocarcinoma of the pancreas. Shire plc.
Shire plc announced that the European Commission has granted Marketing Authorization 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 (5-FU) and leucovorin (LV), 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 (EU), as well as in Iceland, Liechtenstein and Norway. Onivyde was previously approved in the U.S. by the FDA, in October 2015.
Comment:In September 2015, the European Society of Medical Oncology (ESMO) stated that use of MM-398 (Onivyde) when available in all countries, may be the best option for patients following gemcitabine-based therapy. Gemcitabine-based therapy is commonly used as a first-line treatment for patients with metastatic disease or locally advanced disease that cannot be treated with surgery, or as adjuvant therapy.
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