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Lorlatinib (Lorbrena) for Non-Small Cell Lung Cancer — Details

Project Number pCODR 10183
Brand Name Lorbrena
Generic Name Lorlatinib
Strength 25 mg & 100 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: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib.
Review Status Under Review
Pre Noc Submission No
NOC Date February 22, 2019
Manufacturer Pfizer Canada ULC
Sponsor Pfizer Canada ULC
Submission Date June 11, 2019
Submission Deemed Complete June 25, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ June 25, 2019
Check-point meeting August 21, 2019
pERC Meeting (target date) November 21, 2019
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.