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Tagrisso for Non-Small Cell Lung Cancer (first line) – Details

Project Number PC0137-000
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 Complete
Pre Noc Submission Yes
NOC Date July 10, 2018
Manufacturer AstraZeneca Canada Inc.
Sponsor AstraZeneca Canada Inc.
Submission Date May 16, 2018
Submission Deemed Complete May 24, 2018
Submission Type Initial
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 November 1, 2018
Feedback Deadline ‡ November 15, 2018
pERC Reconsideration Meeting December 13, 2018
Final Recommendation Issued January 4, 2019
Notification to Implement Issued January 21, 2019
Therapeutic Area Non-Small Cell Lung Cancer (NSCLC) (first line)
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.