| Project Number | pCODR 10096 |
|---|---|
| Brand Name | Onivyde |
| Generic Name | Nanoliposomal Irinotecan |
| Tumour Type | Gastrointestinal |
| Indication | Metastatic Pancreatic Cancer |
| Funding Request | For second-line treatment of metastatic adenocarcinoma of the pancreas in combination with 5-fluorouracil (5-FU) and leucovorin in adult patients who have been previously treated with gemcitabine-based therapy |
| Review Status | File-Closed Not Submitted |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Baxalta Canada Corporation |
| Submitter | Baxalta Canada Corporation |
| Clarification | The submitter notified pCODR that they will not be filing the submission. |
| Submission Date (Target Date) | |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline (target date based on target submission date) ‡ | |
| 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.