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FDA Withdraws Durvalumab Indication For Bladder Cancer

by Pooja Shete on Feb 27 2021 11:47 PM

FDA Withdraws Durvalumab Indication For Bladder Cancer
AstraZeneca has announced that the immunotherapy drug Durvalumab (Imfinzi) has failed to improve overall survival in unresectable metastatic bladder cancer in a phase 3 trial. This indication will be withdrawn in the United States.
This withdrawal will not affect its indication outside the United States, nor will it affect the other approved durvalumab indications within the United States. US Food and Drug Administration (FDA) has approved durvalumab for the treatment of extensive-stage small cell lung cancer and in the curative-intent setting of unresectable, stage III non–small cell lung cancer after chemoradiotherapy.

The company will continue clinical trials of durvalumab in various combinations for the treatment of bladder cancer.

FDA has granted durvalumab accelerated approval in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-containing chemotherapy or who experience disease progression within 12 months of neoadjuvant or adjuvant treatment with that chemotherapy. In the phase 3 DANUBE trial conducted in patients with unresectable metastatic bladder cancer, neither durvalumab alone nor durvalumab plus tremelimumab improved survival when compared to the standard-of-care chemotherapy.

Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a company press statement 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."

Source-Medindia


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