FDA to review Roche’s bladder cancer drug on priority basis
ZURICH – The US Food and Drug Administration has granted a priority review status to Roche’s immunotherapy to treat advanced bladder cancer, the Swiss pharmaceutical maker said on Tuesday.
The drug, atezolizumab, was granted the status based on results of a study, which showed the drug shrank tumors and that a majority of patients continued to respond to the treatment after nearly a year of follow up,” Roche Chief Medical Officer Sandra Horning said.
The FDA will decide on approval by Sept. 12, the company said.
Roche is banking on atezolizumab to bring in billions in revenue by 2020 as a centre-piece of its strategy to counter the threat of biosimilar versions of its older medicines with new drugs to fight cancer. -Reuters