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The manufacturer, Pfizer Canada Inc. has resubmitted to pCODR for the Crizotinib (Xalkori) Advanced NSCLC submission. Please see the Crizotinib (Xalkori) for Advanced NSCLC Details page for information pertaining to the original submission.
|Project Number||pCODR 10017|
|Strength||200mg and 250mg|
|Indication||Advanced Non-Small Cell Lung Cancer|
|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)|
|Review Status||Notification to Implement Issued (Original Submission Complete)|
|Pre Noc Submission||No|
|NOC Date||April 25, 2012|
|Manufacturer||Pfizer Canada Inc.|
|Sponsor||Pfizer Canada Inc.|
|Submission Date||October 23, 2012|
|Submission Deemed Complete||November 2, 2012|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline (target date based on target submission date) ‡|
|Clarification||As per pCODR Procedures D3.2, due to the short time frame between the original submission and the resubmission, pCODR will not be seeking new patient advocacy group input. The most recent patient advocacy group input received on the original submission related to Crizotinib (Xalkori) for Advanced NSCLC will be provided to the Review Team to incorporate into the Clinical and Economic Guidance Reports and to pERC for the purposes of their deliberation.|
|Check-point meeting||December 19, 2012|
|pERC Meeting||February 21, 2013|
|Initial Recommendation Issued||March 7, 2013|
|Feedback Deadline ‡||March 21, 2013|
|pERC Reconsideration Meeting||April 18, 2013|
|Final Recommendation Issued||May 2, 2013|
|Notification to Implement Issued||May 17, 2013|
‡ 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.