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|Project Number||pCODR 10092|
|Strength||150 mg capsule|
|Indication||Non-Small Cell Lung Cancer (with CNS metastases)|
|Funding Request||As monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib and have CNS metastases|
|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||October 3, 2016|
|Submission Deemed Complete||October 11, 2016|
|Submission Type||New Drug|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||October 18, 2016|
|Check-point meeting||November 30, 2016|
|pERC Meeting||February 16, 2017|
|Initial Recommendation Issued||March 3, 2017|
|Feedback Deadline ‡||March 17, 2017|
|pERC Reconsideration Meeting||April 20, 2017|
|Final Recommendation Issued||May 4, 2017|
|Notification to Implement Issued||May 19, 2017|
‡ 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.