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Brigatinib (Alunbrig) for Non-Small Cell Lung Cancer (NSCLC) – Details

Project Number pCODR 10167
Brand Name Alunbrig
Generic Name Brigatinib
Strength 30 mg, 90 mg, and 180 mg
Tumour Type Lung
Indication Non-Small Cell Lung Cancer (NSCLC)
Funding Request For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on or who were intolerant to an ALK inhibitor (crizotinib).
Review Status Under Review
Pre Noc Submission No
NOC Date July 26, 2018
Manufacturer Takeda Canada Inc.
Submitter Takeda Canada Inc.
Submission Date December 5, 2018
Submission Deemed Complete December 19, 2018
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ December 19, 2018
Check-point meeting February 20, 2019
pERC Meeting May 16, 2019
Initial Recommendation Issued (target date) May 31, 2019
Feedback Deadline (target date) ‡ May 14, 2019
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.