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Trifluridine-Tipiracil (Lonsurf) for Gastric Cancer — Details

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 Notification to Implement Issued
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 February 20, 2020
Initial Recommendation Issued March 5, 2020
Feedback Deadline ‡ March 19, 2020
pERC Reconsideration Meeting (target date)
Final Recommendation Issued March 24, 2020
Notification to Implement Issued April 8, 2020

‡ 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.