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Larotrectinib (Vitrakvi) Resubmission - Details

Project Number pCODR 10221
Brand Name Vitrakvi
Generic Name Larotrectinib
Strength 25 mg, 100 mg & 20 mg/mL
Tumour Type Other
Indication Neurotrophic Tyrosine Receptor Kinase
Funding Request For the treatment of adult and pediatric patients with solid tumours that: have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and, have no satisfactory treatment options.
Review Status Open for Input on Submission
Pre Noc Submission No
NOC Date July 10, 2019
Manufacturer Bayer Inc.
Sponsor Bayer Inc.
Submission Date (Target Date) November 13, 2020
Submission Type Resubmission
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ December 4, 2020
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.