MONDAY, April 15, 2019 (HealthDay News) -- Balversa (rdafitinib) has been approved by the U.S. Food and Drug Administration to treat adults with advanced or spreading bladder cancer caused by a genetic defect called FGFR3 or FGFR2, the agency said in a news release.
"We're in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient's specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. Today's approval represents the first personalized treatment targeting susceptible FGFR genetic alternations for patients with metastatic bladder cancer," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.
Bladder cancer is the sixth most common cancer in the United States, the FDA said. About 20 percent of people with the disease have an FGFR mutation.
Balversa was clinically studied in a trial involving 87 people with advanced or metastatic bladder cancer and the FGFR3 or FGFR2 genetic mutation who hadn't responded to chemotherapy, the FDA said. About one-third of those given the drug had a complete or partial response to the medication; the average response lasting about 5 1/2 months.
Common side effects of Balversa included a jump in phosphate levels, mouth sores, feeling tired, changes in kidney function, diarrhea, dry mouth and changes in liver function.
Balversa may trigger serious eye problems, including inflamed eyes, inflamed cornea and disorders of the retina, the agency warned.
Doctors and other health professionals should tell men with female partners of child-bearing potential to use contraception during treatment with Balversa and for one month after the last dose, the FDA said. Women who are pregnant or breastfeeding shouldn't take Balversa because it may harm a developing fetus or newborn.
Balversa is produced by Belgium-based Janssen Pharmaceutical.
The FDA said it also approved a screening test for this type of cancer, the Therascreen FGFR RGQ RT-PCR Kit, developed by Germany-based QIAGEN Manchester Ltd.
Visit the FDA to learn more.