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Imfinzi for Non-Small Cell Lung Cancer – Details

Project Number pCODR 10131
Brand Name Imfinzi
Generic Name Durvalumab
Strength 50 mg
Tumour Type Lung
Indication Non-Small Cell Lung Cancer
Funding Request For the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) following curative intent platinum-based chemoradiation therapy, for up to a maximum of 12 months
Review Status Under Review
Pre Noc Submission No
NOC Date May 4, 2018
Manufacturer AstraZeneca Canada
Submitter AstraZeneca Canada
Submission Date September 21, 2018
Submission Deemed Complete October 5, 2018
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ October 5, 2018
Check-point meeting November 12, 2018
pERC Meeting (target date)
Initial Recommendation Issued (target date)
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.