Balversa erdafitinib

Drug Class

FGFR kinase inhibitor

Mechanism

Inhibits fibroblast growth factor receptor (FGFR) kinases 1, 2, 3, and 4, blocking downstream signaling pathways to impede tumor cell proliferation and survival.

Approved Indication

Locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 genetic alterations after progression on or after prior systemic therapy, per its FDA approval.

What This Means For Patients

Balversa is a targeted oral kinase inhibitor for patients with advanced bladder cancer (urothelial carcinoma) carrying specific FGFR3 genetic mutations. It works by blocking signaling pathways that drive tumor growth and is available under special import policies at Lecheng.

Regulatory Approvals

• FDA — approved (2019) — label

Pivotal Clinical Evidence

• THOR — Loriot et al., N Engl J Med 2023 (NCT03390504) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-full-approval-erdafitinib-locally-advanced-or-metastatic-urothelial-carcinoma
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212018s000lbl.pdf