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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Shire’s Onivyde (irinotecan pegylated liposomal formulation) to treat metastatic adenocarcinoma.
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The Onivyde, which is also known as nal-IRI or MM-398, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), has been recommended, for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine based therapy.
The CHMP positive opinion was based on pivotal and Phase 3 NAPOLI-1 data, which showed nal-IRI combined with 5-FU and LV improved overall survival (OS) (primary endpoint), as well as progression-free survival (PFS) and objective response rate (ORR) relative to the 5-FU and LV control arm (secondary endpoints).
The CHMP’s positive opinion will be reviewed by the European Commission (EC), which grants marketing authorizations for medicines in the European Union (EU).
Onivyde is a formulation (encapsulation) of irinotecan in a long-circulating liposomal form, designed to improve delivery and the length of exposure of irinotecan.
Shire has taken the responsibility to develop and commercialize Onivyde outside US and Taiwan under an exclusive licensing agreement with Merrimack Pharmaceuticals.
In the US, Merrimack received FDA approval for Onivyde in the US to treat patients with metastatic adenocarcinoma of the pancreas who have progressed following treatment with gemcitabine-based therapy.
Shire R&D head Philip Vickers said: “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.”