U.S. FDA approves J&J's bladder cancer drug


By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration on Friday approved Johnson & Johnson's treatment for patients with a form of bladder cancer.

Balversa (erdafitinib) is the first approved treatment for bladder cancer that targets a genetic alteration known as FGFR3 or FGFR2, the FDA said.

Patients can take the drug using an FDA-approved companion diagnostic device.

The approval was based on a clinical trial in 87 patients whose cancer had progressed after chemotherapy. The trial showed that about 32 percent of patients responded to J&J's treatment.

The response lasted for an average of approximately five-and-a-half months. 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 Balversa were seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.

"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," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a news release.

"Today's approval represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer. FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs," said Pazdur.

Shares of Incyte Corp, which is also developing a cancer treatment with the same mechanism of action that targets mutations in the FGFR molecules, were down 2 percent at $79.45.

J&J shares were flat at $135.45 in afternoon trading.

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