pemigatinib

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.​
  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 open18-Oct-24
Call for patient/clinician input closed13-Dec-24
Submission received18-Oct-24
Submission accepted01-Nov-24
Review initiated04-Nov-24
Draft CADTH review report(s) provided to sponsor for comment20-Jan-25
Deadline for sponsors comments30-Jan-25
CADTH review report(s) and responses to comments provided to sponsor28-Feb-25
Expert committee meeting (initial)12-Mar-25
Draft recommendation issued to sponsorMarch 25, 2025
To
March 27, 2025
Draft recommendation posted for stakeholder feedback03-Apr-25
End of feedback period17-Apr-25