Immunotherapy drug- Durvalumab’s indication for the treatment of bladder cancer has been withdrawn in the US after it failed to improve survival.
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 This indication will be withdrawn in the United States.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.
‘Durvalumab is an immunotherapy drug approved for the treatment of extensive-stage small cell lung cancer. In the US, FDA has withdrawn Durvalumab’s indication for the treatment unresectable metastatic bladder cancer after it failed to improve survival.’
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The company will continue clinical trials of durvalumab in various combinations for the treatment of bladder cancer.Read More..
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