A year after trial failure, AstraZeneca withdraws Imfinzi's maiden indication in bladder cancer — but execs look to the bright side
Lung cancer is the arena where AstraZeneca’s Imfinzi has made its mark, but those who have watched the PD-L1 drug since it was still known as durvalumab might remember that its very first FDA OK — an accelerated approval granted in May 2017 — was for bladder cancer.
After “consultation with the FDA,” AstraZeneca says it has voluntarily withdrawn this indication in the US, meaning it will no longer be marketing it to patients with locally advanced or metastatic bladder cancer who have been treated with chemotherapy. Patients currently on the therapy are advised to consult with their doctors.
The withdrawal comes almost a year after Imfinzi flunked a confirmatory trial dubbed DANUBE, failing to help patients live longer compared to chemo alone. The accelerated OK had been based on tumor response rate and duration of response.
Dave Fredrickson, EVP of the oncology business unit, cushioned the news by highlighting that immunotherapies have been bringing new treatment options “at an unprecedented pace” over the past few years.
“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 and remain committed to bringing new and innovative options to patients,” he said. “In the last three years, Imfinzi has become an important standard of care in multiple lung cancer settings, an area of considerable focus for AstraZeneca.”
The company noted that the withdrawal doesn’t impact the indication outside the US; it had put an EU filing on the backburner after the CHMP decided against a speedy review back in 2017.