| Project Number | pCODR 10035 |
|---|---|
| Brand Name | Zaltrap |
| Generic Name | Aflibercept |
| Strength | 25mg/mL |
| Tumour Type | Gastrointestinal |
| Indication | Metastatic Colorectal Cancer |
| Funding Request | In combination with irinotecan-fluoropyrimidine (FOLFIRI) based therapy for patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | February 12, 2014 |
| Manufacturer | Sanofi-aventis Canada Inc. |
| Sponsor | Sanofi-aventis Canada Inc. |
| Submission Date | November 26, 2013 |
| Submission Deemed Complete | December 10, 2013 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | December 10, 2013 |
| Check-point meeting | January 24, 2014 |
| pERC Meeting | June 19, 2014 |
| Initial Recommendation Issued | July 4, 2014 |
| Feedback Deadline ‡ | July 18, 2014 |
| pERC Reconsideration Meeting | August 21, 2014 |
| Final Recommendation Issued | September 5, 2014 |
| Notification to Implement Issued | September 22, 2014 |
| Clarification | A delay in the receipt of Category 2 Part 2 requirements has impacted the review timeline. |
‡ 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.
