| Project Number | pCODR 10197 |
|---|---|
| Brand Name | Lonsurf |
| Generic Name | Trifluridine-Tipiracil |
| Strength | 15 mg / 6.14 mg and 20 mg / 8.19 mg |
| Tumour Type | Gastrointestinal |
| Indication | Gastric Cancer |
| Funding Request | For the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | November 19, 2019 |
| Manufacturer | Taiho Pharma Canada, Inc. |
| Sponsor | Taiho Pharma Canada, Inc. |
| Submission Date | September 3, 2019 |
| Submission Deemed Complete | September 17, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | September 17, 2019 |
| Check-point meeting | November 6, 2019 |
| pERC Meeting (target date) | February 20, 2020 |
| 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.
