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Imfinzi Approval History

Imfinzi (durvalumab) is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Development History and FDA Approval Process for Imfinzi

DateArticle
May  1, 2017Approval AstraZeneca’s Imfinzi (durvalumab) Receives FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer
Dec  9, 2016US FDA Accepts First Biologics License Application for AstraZeneca’s Durvalumab in Bladder Cancer
Feb 17, 2016Durvalumab Granted Breakthrough Therapy Designation by U.S. FDA for Treatment of Patients with PD-L1 Positive Urothelial Bladder Cancer

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