Last Updated : January 21, 2025
Details
FilesGeneric Name:
pemigatinib
Project Status:
Active
Therapeutic Area:
Cholangiocarcinoma
Manufacturer:
Incyte Biosciences Canada Corporation
Call for patient/clinician input open:
Brand Name:
Pemazyre
Project Line:
Reimbursement Review
Project Number:
PC0391-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults with previously treated, unresectable locally advanced or metastatic CCA with a FGFR2 fusion or other rearrangement.
Submission Type:
Resubmission
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Pemazyre (pemigatinib) for
the treatment of adults with previously treated, unresectable locally advanced
or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement.
- 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 | October 18, 2024 |
|---|---|
| Call for patient/clinician input closed | December 13, 2024 |
| Submission received | October 18, 2024 |
| Submission accepted | November 01, 2024 |
| Review initiated | November 04, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | January 20, 2025 |
| Deadline for sponsors comments | January 30, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | February 28, 2025 |
| Expert committee meeting (initial) | March 12, 2025 |
| Draft recommendation issued to sponsor | March 25, 2025 To March 27, 2025 |
| Draft recommendation posted for stakeholder feedback | April 03, 2025 |
| End of feedback period | April 17, 2025 |
Files
Last Updated : January 21, 2025