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Lonsurf for Metastatic Colorectal Cancer Resubmission – Details

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 Under Review
Pre Noc Submission No
NOC Date January 25, 2018
Manufacturer Taiho Pharma Canada, Inc.
Submitter 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 (target date) April 9, 2019
pERC Meeting (target date)
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.