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Alecensaro for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (second line) – Details

Project Number pCODR 10114
Brand Name Alecensaro
Generic Name Alectinib
Strength 150 mg
Tumour Type Lung
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 Under Review
Pre Noc Submission No
NOC Date September 29, 2016
Manufacturer Hoffmann-La Roche Limited
Submitter 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 (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ 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.