Last Updated : May 3, 2024
Details
Generic Name:
erdafitinib
Project Status:
Pending
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
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harboring susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations, with disease progression during or following at least one line of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy including within 12 months of neoadjuvant or adjuvant therapy. Treatment with BALVERSA® should be initiated following confirmation of a susceptible FGFR genetic alteration using a validated test.
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harboring susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations, with disease progression during or following at least one line of a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy including within 12 months of neoadjuvant or adjuvant therapy. Treatment with BALVERSA® should be initiated following confirmation of a susceptible FGFR genetic alteration using a validated test.
Anticipated Date:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Last Updated : May 3, 2024