The United States Food and Drug Administration (FDA) has granted accelerated approval to Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, for Balversa intended for the treatment of metastatic bladder cancer, it was reported yesterday.

The product is now indicated in the United States for the treatment of adult patients having locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration called FGFR3 or FGFR2, and whose condition had progressed during or after being previously treated with platinum-containing chemotherapy. Accelerated approval was based on a phase 2 trial that featured 87 patients having locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations that had advanced after treatment with chemotherapy.

According to the company, continued approval for its drug for the indication is likely to be based on verification and description of clinical benefit in confirmatory trials. The US FDA stated that patients should be selected for treatment with the Janssen drug using a companion diagnostic device that it has approved.