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Lonsurf for Metastatic Colorectal Cancer – Details

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 Under Review
Pre Noc Submission Yes
NOC Date January 25, 2018
Manufacturer Taiho Pharma Canada, Inc.
Submitter 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 (target date) April 19, 2018
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.