Erdafitinib (Balversa)

General information

Class/mechanism: Tyrosine kinase inhibitor. Erdafitinib inhibits multiple receptor tyrosine kinases (RTKs), including fibroblast growth factor receptors (FGFR) FGFR1, FGFR2, FGFR3, FGFR4, as well as RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT, and VEGFR2. Erdafitinib inhibits FGFR-related phosphorylation and signal transduction, resulting in inhibition and tumor cell death in FGFR-overexpressing tumor cells.
Route: PO
Extravasation: n/a

• Monitor for hyperphosphatemia; dose adjustments may be needed per package insert

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the package insert.

Diseases for which it is established

• Urothelial carcinoma

Patient drug information

• Erdafitinib (Balversa) package insert

History of changes in FDA indication

• 2019-04-12: Accelerated FDA approval for adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations and progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. (Based on BLC2001)
• 2023-01-19: Approved for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. (Based on THOR cohort 1)

History of changes in Health Canada indication

• 2019-10-25: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose tumors have susceptible fibroblast growth factor receptor (FGFR)2 or FGFR3 genetic alterations and who have disease progression during or following at least one line of prior chemotherapy, including within 12 months of neoadjuvant or adjuvant chemotherapy.

Also known as

• Code name: JNJ-42756493
• Brand name: Balversa
• Synonym: Erda