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 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.
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
- 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.
|Call for patient/clinician input open||October 16, 2020|
|Call for patient/clinician input closed||December 04, 2020|
- 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 received||November 16, 2020|
|Submission accepted||November 30, 2020|
|Review initiated||December 01, 2020|
|Draft CADTH review report(s) provided to sponsor for comment||March 02, 2021|
|Deadline for sponsors comments||March 11, 2021|
|CADTH responses on draft review report(s) provided to sponsor||April 05, 2021|
|Expert committee meeting (initial)||April 15, 2021|
|Draft recommendation issued to sponsor||April 29, 2021|
|Draft recommendation posted for stakeholder feedback||May 07, 2021|
|End of feedback period||May 21, 2021|
- Reconsideration: major revisions requested by drug programs.