fruquintinib

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Generic 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
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.
  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 open28-Mar-24
Call for patient/clinician input closed21-May-24
Submission received22-May-24
Submission accepted05-Jun-24
Review initiated06-Jun-24
Draft CADTH review report(s) provided to sponsor for comment21-Aug-24
Deadline for sponsors comments30-Aug-24
CADTH review report(s) and responses to comments provided to sponsor26-Sep-24
Expert committee meeting (initial)09-Oct-24
Draft recommendation issued to sponsor22-Oct-24
Draft recommendation posted for stakeholder feedback31-Oct-24
End of feedback period15-Nov-24