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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 Under Review
Clarification As per Section 4.1.1 subsection a) of the pCODR Procedures, the timeline of the review was temporarily stopped pending rescheduling of the Checkpoint Meeting, as per the request of Shire Canada Inc.
Pre Noc Submission Yes
NOC Date
Manufacturer Shire Canada
Submitter Shire Canada
Submission Date April 27, 2017
Submission Deemed Complete May 4, 2017
Submission Type New Drug
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ May 11, 2017
Check-point meeting (target date) July 12, 2017
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.