| Project Number | pCODR 10137 |
|---|---|
| Brand Name | Tagrisso |
| Generic Name | Osimertinib |
| Strength | 40 mg and 80 mg |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer (first line) |
| Funding Request | For the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations |
| Review Status | Under Review |
| Pre Noc Submission | Yes |
| NOC Date | July 10, 2018 |
| Manufacturer | AstraZeneca Canada Inc. |
| Submitter | AstraZeneca Canada Inc. |
| Submission Date | May 16, 2018 |
| Submission Deemed Complete | May 24, 2018 |
| Submission Type | New Indication |
| Prioritization Requested | Requested and Not Granted |
| Stakeholder Input Deadline ‡ | May 31, 2018 |
| Check-point meeting | July 18, 2018 |
| pERC Meeting | October 18, 2018 |
| Initial Recommendation Issued (target date) | November 1, 2018 |
| 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.