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|Project Number||pCODR 10114|
|Indication||Locally advanced or metastatic non-small cell lung cancer (second line)|
|Funding Request||As monotherapy for the treatment of 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 are intolerant to crizotinib until loss of clinical benefit|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||September 29, 2016|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||August 18, 2017|
|Submission Deemed Complete||August 25, 2017|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Not Granted|
|Stakeholder Input Deadline ‡||September 1, 2017|
|Check-point meeting||October 10, 2017|
|pERC Meeting||January 18, 2018|
|Initial Recommendation Issued||February 1, 2018|
|Feedback Deadline ‡||February 15, 2018|
|pERC Reconsideration Meeting||March 15, 2018|
|Final Recommendation Issued||March 29, 2018|
|Notification to Implement Issued||April 16, 2018|
‡ 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.