Last Updated : February 5, 2025
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...
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | May 03, 2024 |
|---|---|
| Call for patient/clinician input closed | June 28, 2024 |
| Submission received | June 14, 2024 |
| Submission accepted | June 28, 2024 |
| Review initiated | July 02, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | September 26, 2024 |
| Deadline for sponsors comments | October 08, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | October 31, 2024 |
| Expert committee meeting (initial) | November 13, 2024 |
| Draft recommendation issued to sponsor | November 26, 2024 |
| Draft recommendation posted for stakeholder feedback | December 05, 2024 |
| End of feedback period | December 19, 2024 |
| Final recommendation issued to sponsor and drug plans | January 09, 2025 |
| Final recommendation posted | January 28, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 23, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 5, 2025