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

Project Number pCODR 10159
Brand Name Vitrakvi
Generic Name Larotrectinib
Strength 25 mg, 100 mg & 20 mg/mL
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 or metastatic solid tumours harbouring a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. Additional criteria: Age ≥ 1 month; ECOG score of ≤3; Tumour harbouring NTRK1, NTRK2 or NTRK3 gene fusion confirmed by a validated diagnostic testing method; Patients eligible for larotrectinib should have no satisfactory alternative treatments or have progressed following treatment
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date July 10, 2019
Manufacturer Bayer Inc.
Sponsor Bayer Inc.
Submission Date February 25, 2019
Submission Deemed Complete March 29, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ March 11, 2019
Check-point meeting June 4, 2019
pERC Meeting August 15, 2019
Initial Recommendation Issued August 29, 2019
Feedback Deadline ‡ September 13, 2019
pERC Reconsideration Meeting October 17, 2019
Final Recommendation Issued October 31, 2019
Notification to Implement Issued November 15, 2019

‡ 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.