Last Updated : February 8, 2023
Details
FilesGeneric Name:
entrectinib
Project Status:
Complete
Therapeutic Area:
Extracranial solid tumours with NTRK gene fusion
Manufacturer:
Hoffmann-La Roche Ltd.
Brand Name:
Rozlytrek
Project Line:
Reimbursement Review
Project Number:
PC0278-000
Tumour Type:
Other
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Indications:
For the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | December 20, 2021 |
| Clarification: - Patient input submission received from Colorectal Cancer Canada, Canadian Breast Cancer Network, Lung Cancer Canada, and Lung Health Foundation / TheOntario Lung Association | |
| Call for patient/clinician input closed | February 18, 2022 |
| Submission received | January 25, 2022 |
| Submission accepted | February 08, 2022 |
| Review initiated | February 09, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 26, 2022 |
| Deadline for sponsors comments | June 06, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | September 01, 2022 |
| Expert committee meeting (initial) | September 14, 2022 |
| Draft recommendation issued to sponsor | September 28, 2022 |
| Draft recommendation posted for stakeholder feedback | October 06, 2022 |
| End of feedback period | October 21, 2022 |
| Final recommendation issued to sponsor and drug plans | November 03, 2022 |
| Final recommendation posted | November 21, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 17, 2022 |
| CADTH review report(s) posted | February 07, 2023 |
Files
Last Updated : February 8, 2023