cabozantinib

Details

Files
Generic Name:
cabozantinib
Project Status:
Complete
Therapeutic Area:
Advanced or metastatic renal cell carcinoma
Manufacturer:
Ipsen Biopharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Cabometyx
Project Line:
Reimbursement Review
Project Number:
PC0312-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Cabometyx in combination with nivolumab for the first-line treatment of adult patients with advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Cabometyx in combination with nivolumab, is indicated for the first-line treatment of adult patients with advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC
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 openJanuary 19, 2023
Call for patient/clinician input closedMarch 13, 2023
Submission receivedFebruary 17, 2023
Submission acceptedApril 14, 2023
Review initiatedApril 21, 2023
Draft CADTH review report(s) provided to sponsor for commentJuly 17, 2023
Deadline for sponsors commentsJuly 26, 2023
CADTH review report(s) and responses to comments provided to sponsorAugust 31, 2023
Expert committee meeting (initial)September 13, 2023
Draft recommendation issued to sponsorSeptember 25, 2023
Draft recommendation posted for stakeholder feedbackOctober 05, 2023
End of feedback periodOctober 20, 2023
Final recommendation issued to sponsor and drug plansNovember 03, 2023
Final recommendation postedNovember 27, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 20, 2023
CADTH review report(s) postedFebruary 14, 2024