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Erbitux for Metastatic Colorectal Cancer - Details

Project Number pCODR 10031
Brand Name Erbitux
Generic Name Cetuximab
Strength 2mg/ml, 100mg, 50ml single use vial
Tumour Type Gastrointestinal
Indication Metastatic Colorectal Cancer
Funding Request For the treatment of EGFR-expressing K-RAS wild Type metastatic colorectal carcinoma (mCRC) in combination with FOLFIRI (Irinotecan, 5-fluorouracil, leucovorin) for first line treatment
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date December 20, 2012
Manufacturer Bristol-Myers Squibb Canada
Submitter pCODR Provincial Advisory Group
Clarification Bristol-Myers Squibb Canada had requested a voluntary withdrawal of the Cetuximab (Erbitux) for mCRC Submission in anticipation of new clinical information and possible resubmission. As per pCODR Procedures B3.1.6.2 b), the pCODR Provincial Advisory Group has decided to continue the review as a PAG Submission in order to obtain a final recommendation that provinces can act on if needed.
Submission Date June 10, 2013
Submission Deemed Complete June 21, 2013
Submission Type New Indication
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ June 24, 2013
Check-point meeting August 27, 2013
pERC Meeting October 17, 2013
Initial Recommendation Issued October 31, 2013
Feedback Deadline ‡ November 15, 2013
pERC Reconsideration Meeting December 19, 2013
Final Recommendation Issued January 10, 2014
Notification to Implement Issued January 27, 2014

‡ 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.