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|Project Number||pCODR 10159|
|Strength||25 mg, 100 mg & 20 mg/mL|
|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|
|Submission Date||February 25, 2019|
|Submission Deemed Complete||March 29, 2019|
|Submission Type||New Drug|
|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.