| Project Number | pCODR 10173 |
|---|---|
| Brand Name | Lonsurf |
| Generic Name | Trifluridine and Tipiracil |
| Strength | 15 mg & 20 mg |
| Tumour Type | Gastrointestinal |
| Indication | Metastatic Colorectal Cancer |
| Funding Request | Treatment of adult patients with mCRC who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | No |
| NOC Date | January 25, 2018 |
| Manufacturer | Taiho Pharma Canada, Inc. |
| Sponsor | Taiho Pharma Canada, Inc. |
| Submission Date | January 21, 2019 |
| Submission Deemed Complete | February 4, 2019 |
| Submission Type | Resubmission |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | February 4, 2019 |
| Check-point meeting | April 9, 2019 |
| pERC Meeting | June 20, 2019 |
| Initial Recommendation Issued | July 5, 2019 |
| Feedback Deadline ‡ | July 19, 2019 |
| pERC Reconsideration Meeting | August 15, 2019 |
| Final Recommendation Issued | August 29, 2019 |
| Notification to Implement Issued | September 16, 2019 |
‡ 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.
