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Alecensaro for Non-Small Cell Lung Cancer (first line) – Details

Project Number pCODR 10125
Brand Name Alecensaro
Generic Name Alectinib
Strength 150 mg
Tumour Type Lung
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
Submitter 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.