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Trifluridine and Tipiracil (Lonsurf) for Metastatic Colorectal Cancer Resubmission – Details

Project Number PC0173-000
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 Complete
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
Therapeutic Area mCRC Resubmission
Recommendation Type Do not reimburse

‡ 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.