Balversa is the first approved drug in a class known as FGFR inhibitors that targets growth factor receptors involved in cell growth and division.
The drug is approved for use in patients whose cancer has progressed during or after chemotherapy and have specific genetic alterations known as FGFR3 or FGFR2. Patients will be selected for therapy with Balversa using an FDA-approved companion diagnostic device that will identify the genetic mutations, the agency said.
Bladder cancer is the sixth most common cancer in the United States, with the FGFR alterations present in about one in five patients.
“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," Richard Pazdur, head of the FDA's oncology products division, said in a statement.
J&J shares closed up 0.5 percent at $135.98. Shares of Incyte Corp, which is also developing a FGFR inhibitor, closed down 2 percent at $79.40.
The approval was based on a small 87-patient trial in which about a third of subjects experienced tumor shrinkage. The median duration before disease progression was 5.4 months.