AstraZeneca PLC (LON:AZN) announced it has voluntarily withdrawn the use of Imfinzi in patients with locally advanced or metastatic bladder cancer in the US.
The decision was made in consultation with the US Food and Drug Administration (FDA).
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In 2017, Imfinzi was granted accelerated approval based on data from the first stage of trials that evaluated the candidate in advanced solid tumours, including previously treated bladder cancer.
However, the final stage of studies did not meet its primary goals for this type of cancer last year.
The withdrawal is in line with FDA guidance on accelerated approvals that did not meet post-marketing requirements, as part of a broader industry-wide evaluation.
It is not impacting the indication outside the US nor other approved Imfinzi indications in the US or abroad.
Patients with metastatic bladder cancer currently using Imfinzi will be notified and moved to other drugs.
“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,” Dave Fredrickson, Executive Vice President at the Oncology Business Unit, said in a statement.
“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."