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Alecensaro for Non-Small Cell Lung Cancer (with CNS metastases) – Details

Project Number pCODR 10092
Brand Name Alecensaro
Generic Name Alectinib
Strength 150 mg capsule
Tumour Type Lung
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
Submitter 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.