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Zaltrap for Metastatic Colorectal Cancer - Details

Project Number pCODR 10035
Brand Name Zaltrap
Generic Name Aflibercept
Strength 25mg/mL
Tumour Type Gastrointestinal
Indication Metastatic Colorectal Cancer
Funding Request In combination with irinotecan-fluoropyrimidine (FOLFIRI) based therapy for patients with metastatic colorectal cancer previously treated with an oxaliplatin-containing regimen
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date February 12, 2014
Manufacturer Sanofi-aventis Canada Inc.
Submitter Sanofi-aventis Canada Inc.
Submission Date November 26, 2013
Submission Deemed Complete December 10, 2013
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ December 10, 2013
Check-point meeting January 24, 2014
pERC Meeting June 19, 2014
Initial Recommendation Issued July 4, 2014
Feedback Deadline ‡ July 18, 2014
pERC Reconsideration Meeting August 21, 2014
Final Recommendation Issued September 5, 2014
Notification to Implement Issued September 22, 2014
Clarification A delay in the receipt of Category 2 Part 2 requirements has impacted the review timeline.

‡ 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.