Last Updated : October 31, 2024
Details
FilesGeneric Name:
erdafitinib
Project Status:
Active
Therapeutic Area:
locally advanced unresectable or metastatic urothelial carcinoma (UC)
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Balversa
Project Line:
Reimbursement Review
Project Number:
PC0375-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
BALVERSA® (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy. BALVERSA® should not be used for the treatment of patients who are eligible for and have not received prior programmed death receptor-1 (PD-1) or programmed death-ligand 1(PD-L1) inhibitor therapy. Treatment with BALVERSA® should be initiated following confirmation of a susceptible FGFR genetic alteration using a validated test.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
BALVERSA® (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy. BALVERSA® should not be used for the treatment of patients who are eligible for and have not received prior programmed death receptor-1 (PD-1) or programmed death-ligand 1(PD-L1) inhibitor therapy. Treatment with BALVE...
- 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 | 03-May-24 |
|---|---|
| Call for patient/clinician input closed | 28-Jun-24 |
| Submission received | 14-Jun-24 |
| Submission accepted | 28-Jun-24 |
| Review initiated | 02-Jul-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 26-Sep-24 |
| Deadline for sponsors comments | 08-Oct-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 31-Oct-24 |
| Expert committee meeting (initial) | 13-Nov-24 |
| Draft recommendation issued to sponsor | November 25, 2024 To November 27, 2024 |
| Draft recommendation posted for stakeholder feedback | 05-Dec-24 |
| End of feedback period | 19-Dec-24 |
Files
Last Updated : October 31, 2024