| 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 |
| Sponsor | 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.
