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Dacomitinib for Non-Small Cell Lung Cancer – Details

Project Number pCODR 10129
Brand Name Dacomitinib
Generic Name TBD
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 Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Pfizer Canada Inc.
Submitter 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 (target date) December 4, 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.