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Project Number | pCODR 10129 |
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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.