larotrectinib


( Last Updated : September 14, 2021)
Generic Name:
larotrectinib
Project Status:
Active
Therapeutic Area:
Solid tumours with NTRK gene fusion
Manufacturer:
Bayer Inc.
Brand Name:
Vitrakvi
Project Line:
Reimbursement Review
Project Number:
PC0221-000
Tumour Type:
Other
NOC Status at Filing:
Post NOC

Details


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
Fee Schedule:
Schedule A
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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.

Expert committee meetingAugust 11, 2021
Final recommendation issued to sponsor and drug plansAugust 25, 2021
Final recommendation postedSeptember 13, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 09, 2021
CADTH review report(s) posted