The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal. The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.
The National Institute for Health and Care Excellence (NICE) has issued draft guidance rejecting Onivyde (nanoliposomal encapsulated irinotecan) from Shire...
The FDA has approved Onivyde (irinotecan liposome injection) from Merrimack Pharma, in combination with fluorouracil and leucovorin, to treat patients...
-The National Institute for Health and Care Excellence (NICE) published final guidance rejecting Onivyde (nanoliposomal encapsulated irinotecan) from Shire plc, in...
Merrimack Pharmaceuticals has announced that an updated overall survival analysis of the Phase III NAPOLI-1 study of Onivyde (irinotecan liposome...
Merrimack and Baxalta have announced that The Lancet has published results of the NAPOLI-1: a global, randomised, open-label, phase III...
Shire plc announced that the European Commission has granted Marketing Authorization of Onivyde (pegylated liposomal irinotecan hydrochloride trihydrate), also known...
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.
The FDA has accepted a supplemental new drug application (sNDA) seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection (Onivyde) plus 5-fluorouracil (5-FU), leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC)