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Xalkori for Advanced NSCLC - Resubmission - Details

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.

Brand Name Xalkori
Generic Name Crizotinib
Strength 200mg and 250mg
Tumour Type Lung
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.
Submitter Pfizer Canada Inc.
Submission Date October 23, 2012
Submission Deemed Complete November 2, 2012
Submission Type Resubmission
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.