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.
Until today.
After “consultation with the FDA,” AstraZeneca says it has voluntarily withdrawn this indication in the US, meaning it will no longer be marketing it to patients with locally advanced or metastatic bladder cancer who have been treated with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.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.