Last Updated : November 12, 2024
Details
Generic 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 | 18-Oct-24 |
|---|---|
| Call for patient/clinician input closed | 13-Dec-24 |
| Submission received | 18-Oct-24 |
| Submission accepted | 01-Nov-24 |
| Review initiated | 04-Nov-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 20-Jan-25 |
| Deadline for sponsors comments | 30-Jan-25 |
| CADTH review report(s) and responses to comments provided to sponsor | 28-Feb-25 |
| Expert committee meeting (initial) | 12-Mar-25 |
| Draft recommendation issued to sponsor | March 25, 2025 To March 27, 2025 |
| Draft recommendation posted for stakeholder feedback | 03-Apr-25 |
| End of feedback period | 17-Apr-25 |
Last Updated : November 12, 2024