| Project Number | pCODR 10032 |
|---|---|
| Brand Name | Giotrif |
| Generic Name | Afatinib |
| Strength | 20mg, 30mg, and 40mg tablets |
| Tumour Type | Lung |
| Indication | Advanced Non Small Cell Lung Cancer |
| Funding Request | For the first line treatment of EGFR Mutation Positive, Advanced Non-Small Cell Lung Cancer patients |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | November 1, 2013 |
| Manufacturer | Boehringer Ingelheim Canada Ltd. |
| Sponsor | Boehringer Ingelheim Canada Ltd. |
| Submission Date | June 7, 2013 |
| Submission Deemed Complete | June 19, 2013 |
| Submission Type | New Drug |
| Prioritization Requested | Not Requested |
| Stakeholder Input Deadline ‡ | June 21, 2013 |
| Check-point meeting | September 30, 2013 |
| pERC Meeting | February 20, 2014 |
| Initial Recommendation Issued | March 6, 2014 |
| Feedback Deadline ‡ | March 20, 2014 |
| pERC Reconsideration Meeting | April 17, 2014 |
| Final Recommendation Issued | May 2, 2014 |
| Notification to Implement Issued | May 20, 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.
