fruquintinib

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Generic Name:
fruquintinib
Project Status:
Complete
Therapeutic Area:
Metastatic colorectal cancer (mCRC)
Manufacturer:
Takeda Canada Inc.
Call for patient/clinician input open:
Brand Name:
Fruzaqla
Project Line:
Reimbursement Review
Project Number:
PC0352-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
  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 openMarch 28, 2024
Call for patient/clinician input closedMay 21, 2024
Submission receivedMay 22, 2024
Submission acceptedJune 05, 2024
Review initiatedJune 06, 2024
Draft CADTH review report(s) provided to sponsor for commentAugust 21, 2024
Deadline for sponsors commentsAugust 30, 2024
CDA-AMC review report(s) and responses to comments provided to sponsorSeptember 26, 2024
Expert committee meeting (initial)October 09, 2024
Draft recommendation issued to sponsorOctober 22, 2024
Draft recommendation posted for stakeholder feedbackOctober 31, 2024
End of feedback periodNovember 15, 2024
Final recommendation issued to sponsor and drug plansNovember 27, 2024
Final recommendation postedDecember 13, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 11, 2024
CDA-AMC review report(s) postedApril 04, 2025