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 not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2019) — Sources

Pivotal Clinical Evidence

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

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