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Vizimpro for Non-Small Cell Lung Cancer – Details

Project Number pCODR 10129
Brand Name Vizimpro
Generic Name Dacomitinib
Strength 15 mg, 30 mg & 45 mg
Tumour Type Lung
Indication Non-Small Cell Lung Cancer
Funding Request For the first-line treatment of patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date February 26, 2019
Manufacturer Pfizer Canada Inc.
Sponsor Pfizer Canada Inc.
Submission Date September 19, 2018
Submission Deemed Complete October 3, 2018
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ October 3, 2018
Check-point meeting December 4, 2018
pERC Meeting March 21, 2019
Initial Recommendation Issued April 4, 2019
Feedback Deadline ‡ April 18, 2019
pERC Reconsideration Meeting May 16, 2019
Final Recommendation Issued May 31, 2019
Notification to Implement Issued June 17, 2019

‡ 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.