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|Project Number||pCODR 10183|
|Strength||25 mg & 100 mg|
|Indication||Non-Small Cell Lung Cancer (NSCLC)|
|Funding Request||For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||February 22, 2019|
|Manufacturer||Pfizer Canada ULC|
|Sponsor||Pfizer Canada ULC|
|Submission Date||June 11, 2019|
|Submission Deemed Complete||June 25, 2019|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||June 25, 2019|
|Check-point meeting||August 21, 2019|
|pERC Meeting||November 21, 2019|
|Initial Recommendation Issued||December 5, 2019|
|Feedback Deadline ‡||December 19, 2019|
|pERC Reconsideration Meeting||January 16, 2020|
|Final Recommendation Issued||January 30, 2020|
|Notification to Implement Issued||February 14, 2020|
‡ 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.