Roche Holding AG has announced that its most advanced experimental drug to harness the immune system in the fight against cancer may win U.S. regulatory approval this year, becoming the first such treatment aiming to help those diagnosed with bladder cancer.
According to reports, the drug may also get U.S. approval this year for treating a type of lung cancer.
The U.S. Federal Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the medicine, called atezolizumab, and has granted Priority Review.
Atezolizumab may generate around $3 billion in sales by 2020, according to reports from Bloomberg.
“We are very optimistic about the hope for immuno-oncology and our role,” said Daniel O’Day, Roche’s head of pharmaceuticals, reports Bloomberg. “We will be entering the market soon with atezolizumab in a new indication, bladder cancer, which today, in fact for the past 30 years, hasn’t had anything really new come to the market.”
A decision by the FDA is expected by Oct. 19, 2016.