AstraZeneca to withdraw Imfinzi U.S. indication for advanced bladder cancer
(Reuters) – AstraZeneca will voluntarily withdraw the use of its cancer drug Imfinzi to treat advanced bladder cancer in the United States after it failed to meet post-approval requirements, the Anglo-Swedish drugmaker said on Monday.
Imfinzi, mainly a lung cancer treatment, was granted accelerated approval for the bladder cancer indication in 2017, and the withdrawal does not impact markets outside the United States, the company said.
The treatment failed the main goal of a late-state trial last year and the decision was based in consultation with U.S. authorities, the company said.
“While the withdrawal in previously treated metastatic bladder cancer is disappointing, we respect the principles FDA set out when the accelerated approval pathway was founded,” Dave Fredrickson, executive vice president of the company’s oncology business division, said in a statement.