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| Project Number | pCODR 10076 |
|---|---|
| Brand Name | Tagrisso |
| Generic Name | Osimertinib |
| Strength | 40 mg and 80 mg Tablets |
| Tumour Type | Lung |
| Indication | Non-Small Cell Lung Cancer |
| Funding Request | For the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | July 5, 2016 |
| Manufacturer | Astra Zeneca Canada Inc |
| Sponsor | Astra Zeneca Canada Inc |
| Submission Date | April 1, 2016 |
| Submission Deemed Complete | April 8, 2016 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Not Granted |
| Stakeholder Input Deadline ‡ | April 15, 2016 |
| Check-point meeting | May 24, 2016 |
| pERC Meeting | February 16, 2017 |
| Clarification | The timeline of the review was temporarily stopped, pending receipt of the additional information from the submitter. The timeline of the review has resumed as the additional information has now been provided and a new pERC date has been set by pCODR. |
| Initial Recommendation Issued | March 3, 2017 |
| Feedback Deadline ‡ | March 17, 2017 |
| pERC Reconsideration Meeting | April 20, 2017 |
| Final Recommendation Issued | May 4, 2017 |
| Notification to Implement Issued | May 19, 2017 |
‡ 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.
