Last Updated : December 23, 2024
Details
FilesGeneric Name:
fruquintinib
Project Status:
Active
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
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:
- 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.
| Call for patient/clinician input open | 28-Mar-24 |
|---|---|
| Call for patient/clinician input closed | 21-May-24 |
| Submission received | 22-May-24 |
| Submission accepted | 05-Jun-24 |
| Review initiated | 06-Jun-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 21-Aug-24 |
| Deadline for sponsors comments | 30-Aug-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 26-Sep-24 |
| Expert committee meeting (initial) | 09-Oct-24 |
| Draft recommendation issued to sponsor | 22-Oct-24 |
| Draft recommendation posted for stakeholder feedback | 31-Oct-24 |
| End of feedback period | 15-Nov-24 |
| Final recommendation issued to sponsor and drug plans | 27-Nov-24 |
| Final recommendation posted | 13-Dec-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 11-Dec-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : December 23, 2024