US FDA approves Johnson & Johnson's bladder cancer drug

The U.S. Food and Drug Administration on Friday approved Johnson & Johnson’s treatment for patients with a form of bladder cancer.

A Johnson & Johnson building is shown in Irvine, California FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake

REUTERS: The U.S. Food and Drug Administration on Friday approved Johnson & Johnson’s treatment for patients with a form of bladder cancer.

The green signal to the drug, Balversa, makes it 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.

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 US$79.45.

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

(Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli and James Emmanuel)