| Project Number | pCODR 10107 |
|---|---|
| Brand Name | Onivyde |
| Generic Name | Irinotecan Liposome |
| Strength | 4.3 mg/mL |
| 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 | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | August 9, 2017 |
| Manufacturer | Shire Canada |
| Sponsor | Shire Canada |
| 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. |
| 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 | July 12, 2017 |
| pERC Meeting | October 19, 2017 |
| Initial Recommendation Issued | November 2, 2017 |
| Feedback Deadline ‡ | November 16, 2017 |
| pERC Reconsideration Meeting | December 14, 2017 |
| Final Recommendation Issued | January 5, 2018 |
| Notification to Implement Issued | January 22, 2018 |
‡ 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.
