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.
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)