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larotrectinib

Last Updated: December 23, 2020
Result type: Reports
Project Number: PC0221-000
Product Line: Reimbursement Review

Generic Name: larotrectinib

Brand Name: Vitrakvi

Manufacturer: Bayer Inc.

Therapeutic Area: Solid tumours with NTRK gene fusion

Indications: For the treatment of adult and pediatric patients with solid tumou​​​rs 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.

Manufacturer Requested Reimbursement Criteria1: 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.

Submission Type: Resubmission

Tumour Type: Other

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input openOctober 16, 2020
Call for patient/clinician input closedDecember 04, 2020
Clarification:

- Patient input submission received from Lung Cancer Canada, The Canadian Breast Cancer Network, Colorectal Cancer Canada, Canadian Cancer Survivor Network and Sarcoma Cancer Foundation of Canada

Submission receivedNovember 16, 2020
Submission acceptedNovember 30, 2020
Review initiatedDecember 01, 2020
Draft CADTH review report(s) provided to sponsor for commentMarch 02, 2021
Deadline for sponsors commentsMarch 11, 2021
CADTH responses on draft review report(s) provided to sponsorApril 05, 2021
Expert committee meeting (initial)April 15, 2021
Draft recommendation issued to sponsorApril 29, 2021
Draft recommendation posted for stakeholder feedbackMay 07, 2021
End of feedback periodMay 21, 2021
Clarification:

- Reconsideration: major revisions requested by drug programs.