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Xalkori for Advanced Non-Small Cell Lung Cancer

The manufacturer, Pfizer Canada Inc. has resubmitted to pCODR for Crizotinib (Xalkori) Advanced NSCLC. Please see the Crizotinib (Xalkori) for Advanced NSCLC Resubmission Details page for more information.

Project Number pCODR 10008
Brand Name Xalkori
Generic Name Crizotinib
Strength 200mg and 250mg
Tumour Type Lung
Indication Advanced Non-Small Cell Lung Cancer
Funding Request Patients with anaplastic lymphoma kinase-(ALK) positive advanced non-small cell lung cancer (NSCLC).
Review Status Notification to Implement Issued (Original Submission Complete)
Pre Noc Submission Yes
NOC Date April 25, 2012
Manufacturer Pfizer Canada Inc.
Submitter Pfizer Canada Inc.
Submission Date March 26, 2012
Submission Deemed Complete April 11, 2012
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ April 11, 2012
Check-point meeting May 23, 2012
pERC Meeting July 19, 2012
Initial Recommendation Issued August 2, 2012
Feedback Deadline ‡ August 17, 2012
pERC Reconsideration Meeting September 20, 2012
Final Recommendation Issued October 4, 2012
Notification to Implement Issued October 22, 2012

‡ 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.