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|Project Number||pCODR 10230|
|Indication||Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer|
|Funding Request||For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) previously untreated with an ALK inhibitor.|
|Review Status||Under Review|
|Pre Noc Submission||Yes|
|Manufacturer||Takeda Canada Inc.|
|Sponsor||Takeda Canada Inc.|
|Submission Date||September 30, 2020|
|Submission Deemed Complete||October 15, 2020|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||October 15, 2020|
|Check-point meeting (target date)||December 16, 2020|
|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.