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|Project Number||pCODR 10125|
|Indication||Non-Small Cell Lung Cancer (first line)|
|Funding Request||For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||June 11, 2018|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||January 15, 2018|
|Submission Deemed Complete||January 22, 2018|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||January 29, 2018|
|Check-point meeting||March 6, 2018|
|pERC Meeting||June 21, 2018|
|Initial Recommendation Issued||July 6, 2018|
|Feedback Deadline ‡||July 20, 2018|
|Final Recommendation Issued||July 25, 2018|
|Notification to Implement Issued||August 10, 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.