Generic Name: erdafitinib

Pronunciation: N/A

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Targeted Therapy Medications

Company: Janssen

Approval Status: Approved

Generic Version Available: No

Experimental Code: N/A

Drug Indication

Balversa is a kinase inhibitor approved for previously treated locally advanced or metastatic bladder cancer (urothelial carcinoma) that carries FGFR genetic mutations.

General Info

Balversa is a kinase inhibitor that blocks the activity of fibroblast growth factor receptor, which plays a role in cell division and maturation. It works against bladder cancer with genetic mutations or fusions in the genes that encode FGFR2 or FGFR3.

In a Phase II study, 32 percent of patients treated with Balversa experienced complete or total tumor shrinkage, including 2 percent with complete regression. The average duration of response was 5.4 months. Balversa was first approved in 2019.


Dosing Info:

Balversa is taken as a once-daily pill. A companion diagnostic test is available to identify people with FGFR2 or FGFR3 mutations.

Side Effects

Common side effects of Balversa include mouth sores, dry mouth, nail problems, hand-foot syndrome (palmar-plantar erythrodysesthesia, with redness, swelling and pain on the palms of the hands and soles of the feet), dry eyes, dry skin, fatigue, diarrhea, changes in the sense of taste (dysgeusia), elevated phosphate levels and certain other laboratory abnormalities. Potential serious side effects may include eye inflammation and disorders of the retina. Balversa may cause fetal harm if used during pregnancy.

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Last Reviewed: April 12, 2019