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|Project Number||pCODR 10054|
|Strength||200mg and 250mg capsules|
|Indication||First Line ALK Positive Advanced NSCLC|
|Funding Request||As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). The study PROFILE1014 will provide data specific to the efficacy and safety of Xalkori for the first-line treatment of ALK-positive advanced NSCLC patient population.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||April 25, 2012|
|Manufacturer||Pfizer Canada Inc.|
|Sponsor||Pfizer Canada Inc.|
|Submission Date||February 17, 2015|
|Submission Deemed Complete||March 3, 2015|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||March 3, 2015|
|Check-point meeting||April 21, 2015|
|pERC Meeting||June 18, 2015|
|Initial Recommendation Issued||July 3, 2015|
|Feedback Deadline ‡||July 17, 2015|
|Final Recommendation Issued||July 21, 2015|
|Notification to Implement Issued||August 6, 2015|
‡ 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.