publication date: Jul. 29, 2016

Drugs and Targets

CHMP Issues Positive Opinion for Onivyde Combination in Pancreatic Adenocarcinoma


The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending marketing authorization of Onivyde (irinotecan liposome injection, nal-IRI), 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.

The opinion will now be reviewed by the European Commission for marketing authorization in the European Union, with a final decision expected this year.

The CHMP recommended a dose of 70 mg/m(2) irinotecan free base (equivalent to 80 mg/m(2) irinotecan hydrochloride salt), every two weeks, which is also the FDA-approved dose regimen for pancreatic cancer. Data supporting the opinion were based on findings from the phase III NAPOLI-1 study.

The Onivyde combination extended overall survival and progression-free survival and increased tumor response rate without compromising quality of life compared to 5-FU/LV in metastatic pancreatic cancer patients who have progressed after gemcitabine-based therapy.

NAPOLI-1 patients were enrolled at 76 sites in 14 countries across North America, Europe, Asia, South America, and Australia. The study evaluated Onivyde (80mg/m2) in combination with 5-FU and LV administered intravenously every two weeks and as a monotherapy (120 mg/m2) administered every three weeks. Each Onivyde arm was compared to a control arm of 5-FU and LV.

Onivyde demonstrated a median overall survival of 6.1 months compared to 4.2 months in the control (HR=0.67; 95% CI 0.49-0.92, p=0.012).

Onivyde is a registered trademark of Merrimack Pharmaceuticals Inc. Shire is responsible for the development and commercialization of Onivyde outside of the U.S. and Taiwan. Onivyde received FDA approval in October 2015 for the treatment of patients with … Continue reading 42-30 CHMP Issues Positive Opinion for Onivyde Combination in Pancreatic Adenocarcinoma

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