entrectinib

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Generic 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:
  1. 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 openDecember 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 closedFebruary 18, 2022
Submission receivedJanuary 25, 2022
Submission acceptedFebruary 08, 2022
Review initiatedFebruary 09, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 26, 2022
Deadline for sponsors commentsJune 06, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 01, 2022
Expert committee meeting (initial)September 14, 2022
Draft recommendation issued to sponsorSeptember 28, 2022
Draft recommendation posted for stakeholder feedbackOctober 06, 2022
End of feedback periodOctober 21, 2022
Final recommendation issued to sponsor and drug plansNovember 03, 2022
Final recommendation postedNovember 21, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 17, 2022
CADTH review report(s) postedFebruary 07, 2023