AstraZeneca withdraws Imfinzi indication for advanced bladder cancer in US
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AstraZeneca voluntarily withdrew durvalumab’s indication for treatment of adults with locally advanced or metastatic bladder cancer.
The company made the decision in consultation with FDA after a phase 3 trial of the agent in this setting failed to meet its primary endpoints.
The FDA granted accelerated approval to durvalumab (Imfinzi, AstraZeneca) — a human monoclonal antibody that binds to PD-L1 — in May 2017 based on tumor response rates and response duration data from Study 1108, a phase 1/phase 2 trial that assessed the efficacy and safety of the agent for patients with previously treated bladder cancer and other advanced solid tumors.
Continued approval was contingent on results of the phase 3 DANUBE trial, which evaluated durvalumab as first-line treatment of metastatic bladder cancer. As Healio previously reported, results released last year showed the study failed to achieve its primary endpoints.
“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 of AstraZeneca’s oncology business unit, said in a company-issued press release.
Patients with metastatic bladder cancer who are receiving durvalumab should consult with their health care providers.
The withdrawal does not affect durvalumab’s approval for advanced bladder cancer in other countries, nor does it affect the agent’s other approved indications in the United States for treatment of certain adults with non-small cell or small cell lung cancers.
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