May 7, 2021

FDA Approves First Targeted Therapy for Metastatic Bladder Cancer

By SPT Staff
Published Online: Thursday, Apr 18, 2019

About a quarter of patients in the study were previously treated with anti PD-L1/PD-1 therapy, which is a standard treatment for patients with locally advanced or metastatic bladder cancer. Responses to erdafitinib were seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.

Common adverse effects reported by patients taking erdafitinib were increased phosphate level, mouth sores, feeling tired, change in kidney function, diarrhea, dry mouth, nails separating from the bed or poor formation of the nail, change in liver function, low sodium levels, decreased appetite, change in sense of taste, anemia, dry skin, dry eyes and hair loss. Other adverse effects include redness, swelling, peeling or tenderness on the hands or feet, constipation, stomach pain, nausea and muscle pain.

In addition, erdafitinib may cause serious eye problems, including inflamed eyes, inflamed cornea, and disorders of the retina. According to the FDA, patients are advised to have eye examinations intermittently and to tell their health care professional right away if they develop blurred vision, loss of vision or other visual changes. Health care professionals are advised to check patients’ blood phosphate level between 14 and 21 days after starting treatment and monthly, and to increase the dose erdafitinib in patients whose serum phosphate is below the target level.

Health care professionals also are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment with erdafitinib and for 1 month after the last dose. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with erdafitinib, and the drug may cause harm to a developing fetus or newborn baby.

This article was originally published on Pharmacy Times. 


FDA approves first targeted therapy for metastatic bladder cancer [news release]. Silver Spring, MD; April 12, 2019: FDA website. Accessed April 12, 2019.

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