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Zykadia for Non-Small Cell Lung Cancer (Resubmission) – Details

Project Number PC0094-000
Brand Name Zykadia (Resubmission)
Generic Name Ceritinib
Tumour Type Lung
Indication Non-Small Cell Lung Cancer
Funding Request For treatment as monotherapy in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib
Review Status Complete
Pre Noc Submission No
NOC Date March 27, 2015
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date October 19, 2016
Submission Deemed Complete November 2, 2016
Submission Type Resubmission
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ November 2, 2016
Check-point meeting December 8, 2016
pERC Meeting February 16, 2017
Initial Recommendation Issued March 3, 2017
Feedback Deadline ‡ March 17, 2017
Final Recommendation Issued March 21, 2017
Notification to Implement Issued April 5, 2017
Therapeutic Area metastatic non-small cell lung cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.