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Xalkori Resubmission for First Line Advanced NSCLC - Details

Project Number pCODR 10054
Brand Name Xalkori
Generic Name Crizotinib
Strength 200mg and 250mg capsules
Tumour Type Lung
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.
Submitter Pfizer Canada Inc.
Submission Date February 17, 2015
Submission Deemed Complete March 3, 2015
Submission Type Resubmission
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.