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|Project Number||pCODR 10167|
|Strength||30 mg, 90 mg, and 180 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 or who were intolerant to an ALK inhibitor (crizotinib).|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||July 26, 2018|
|Manufacturer||Takeda Canada Inc.|
|Sponsor||Takeda Canada Inc.|
|Submission Date||December 5, 2018|
|Submission Deemed Complete||December 19, 2018|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||December 19, 2018|
|Check-point meeting||February 20, 2019|
|pERC Meeting||May 16, 2019|
|Initial Recommendation Issued||May 31, 2019|
|Feedback Deadline ‡||June 14, 2019|
|pERC Reconsideration Meeting||July 18, 2019|
|Final Recommendation Issued||August 1, 2019|
|Notification to Implement Issued||August 19, 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.