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Tagrisso for Non-Small Cell Lung Cancer – Details

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
Submitter 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.