Posted by Michael Wonder on 25 Jul 2016
Onivyde receives positive CHMP opinion for treatment of patients with metastatic adenocarcinoma of the pancreas who have progressed following gemcitabine based therapy
25 July 2016 - The positive opinion is based on a pivotal Phase 3 study showing that Onivyde combined with chemotherapy significantly increased overall survival in patients with metastatic pancreatic cancer after previous gemcitabine based therapy.
Shire today announced that the CHMP of the EMA adopted a positive opinion recommending the marketing authorization for the use of Onivyde (irinotecan pegylated liposomal formulation) 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.
“There has been little improvement in the prognosis for patients with metastatic pancreatic cancer in over 20 years. We therefore welcome the CHMP positive opinion for Onivyde, a regulatory milestone which brings us a step closer to helping patients with this devastating disease.” said Philip J. Vickers, Ph.D., Head of R&D, Shire. “At Shire, we are committed to research and development through innovation in order to identify unique methodologies for treating patients with high unmet needs.”
