| Project Number | pCODR 10122 |
|---|---|
| Brand Name | Lonsurf |
| Generic Name | Trifluridine and Tipiracil |
| Strength | 15 mg & 20 mg |
| Tumour Type | Gastrointestinal |
| Indication | Metastatic Colorectal Cancer |
| Funding Request | For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | January 25, 2018 |
| Manufacturer | Taiho Pharma Canada, Inc. |
| Sponsor | Taiho Pharma Canada, Inc. |
| Submission Date | November 6, 2017 |
| Submission Deemed Complete | November 13, 2017 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | November 20, 2017 |
| Check-point meeting | January 9, 2018 |
| pERC Meeting | April 19, 2018 |
| Initial Recommendation Issued | May 3, 2018 |
| Feedback Deadline ‡ | May 17, 2018 |
| pERC Reconsideration Meeting | June 21, 2018 |
| Final Recommendation Issued | July 6, 2018 |
| Notification to Implement Issued | July 23, 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.
