FDA Approves Balversa (Erdafitinib) for Locally Advanced or Metastatic Urothelial Carcinoma 

Immunotherapy, targeted therapy, surgery, radiation, chemotherapy, intravesical treatment – oh my! These therapeutic options have all been used to treat individuals living with urothelial carcinoma. But the treatment landscape has now significantly changed with Balversa (erdafitinib).

Tristan Manalac reports in Biospace that the U.S. Food and Drug Administration (FDA) recently granted full approval to Balversa for the treatment of locally advanced or metastatic urothelial carcinoma. It was previously indicated for the treatment of certain types of urothelial carcinoma following platinum-based chemotherapy; the drug was given conditional approval in 2019. Balversa is a prescription medication specifically for individuals whose urothelial carcinoma cannot be removed by surgery. This once-daily oral treatment is the first approved oral FGFR kinase inhibitor. It targets and binds to FGFR1, FGFR2, FGFR3, and FGFR4, stopping the cancer’s ability to divide and spread.

Now, with full approval, Balversa is indicated for individuals with susceptible FGFR3 alterations whose condition has progressed following at least one prior line of systemic treatment. The approval follows data from the Phase 3 THOR study. Approximately 630 participants enrolled. Balversa showed promise over the existing standard-of-care for urothelial carcinoma; the therapy improved survival rate by a median of 4 months and reduced mortality risk by 36% when compared to chemotherapy.

Decoding Urothelial Carcinoma

Also referred to as: Bladder cancer; Transitional cell carcinoma

Urothelial carcinoma occurs when cancerous cells form in the urothelial cells, which line the bladder. Since urothelial cells are also found in the ureters, urethra, and renal pelvis, the cancer may manifest there as well. This cancer accounts for approximately 90% of bladder cancer cases. While manageable, particularly in earlier stages, recurrence poses a challenge, making treatment and prevention pivotal focuses in cancer research.

What factors increase urothelial carcinoma risk? This cancer is more common in people who are Caucasian, male, smoke, older than age 55, have chronic bladder infections or a history of bladder cancer, or have been exposed to certain chemicals, substances, or arsenic in drinking water.

If you have this cancer, you may experience blood in your urine (hematuria), painful urination, or bone pain. You may experience changes in bladder habits, such as urinating more or less frequently. Additional symptoms include appetite and weight loss, fatigue and general weakness, pain in the lower back, swollen feet, and an inability to urinate.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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