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Zykadia for Metastatic Non-Small Cell Lung Cancer - Details

Project Number pCODR 10062
Brand Name Zykadia
Generic Name Ceritinib
Strength 150 mg capsule
Tumour Type Lung
Indication Metastatic 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 Notification to Implement Issued
Pre Noc Submission No
NOC Date March 27, 2015
Manufacturer Novartis Pharmaceuticals Inc.
Submitter Novartis Pharmaceuticals Inc.
Submission Date June 5, 2015
Submission Deemed Complete June 12, 2015
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ June 19, 2015
Check-point meeting July 29, 2015
pERC Meeting September 17, 2015
Initial Recommendation Issued October 1, 2015
Feedback Deadline ‡ October 16, 2015
pERC Reconsideration Meeting November 19, 2015
Final Recommendation Issued December 3, 2015
Notification to Implement Issued December 18, 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.