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Onivyde for Metastatic Pancreatic Cancer – Details

Project Number pCODR 10107
Brand Name Onivyde
Generic Name Irinotecan Liposome
Tumour Type Gastrointestinal
Indication Metastatic Pancreatic Cancer
Funding Request For the treatment of metastatic adenocarcinoma of the pancreas in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in adult patients who have been previously treated with gemcitabine-based therapy
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Shire Canada
Submitter Shire Canada
Submission Date (Target Date)
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡
Clarification The Submitter notified pCODR that they will be unable to submit by their original target date and an updated target submission date will be provided by the submitter.  A confirmed stakeholder input deadline date will be provided when the submission is received by pCODR.
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.