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Larotrectinib for Neurotrophic Tyrosine Receptor Kinase (NTRK) Locally Advanced or Metastatic Solid Tumours – Details

Project Number pCODR 10159
Brand Name TBD
Generic Name Larotrectinib
Tumour Type Other
Indication Neurotrophic Tyrosine Receptor Kinase (NTRK) Locally Advanced or Metastatic Solid Tumours
Funding Request For the treatment of adult and pediatric patients with locally advanced ormetastatic solid tumours harboring a Neurotrophic Tyrosine Receptor Kinase NTRK gene fusion, consistent with the proposed Health Canada indication
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Bayer Inc.
Submitter Bayer Inc.
Submission Date (Target Date) February 22, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ March 8, 2019
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.