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

Project Number PC0114-000
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 Complete
Pre Noc Submission No
NOC Date September 29, 2016
Manufacturer Hoffmann-La Roche Limited
Sponsor Hoffmann-La Roche Limited
Submission Date August 18, 2017
Submission Deemed Complete August 25, 2017
Submission Type Initial
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ September 1, 2017
Check-point meeting October 10, 2017
pERC Meeting January 18, 2018
Initial Recommendation Issued February 1, 2018
Feedback Deadline ‡ February 15, 2018
pERC Reconsideration Meeting March 15, 2018
Final Recommendation Issued March 29, 2018
Notification to Implement Issued April 16, 2018
Therapeutic Area Anaplastic Lymphoma Kinase-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.