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Imfinzi Approval History

FDA Approved: Yes (First approved May 1, 2017)
Brand name: Imfinzi
Generic name: durvalumab
Dosage form: Injection
Company: AstraZeneca
Treatment for: Urothelial Carcinoma, Non-Small Cell Lung Cancer

Imfinzi (durvalumab) is an anti-PD-L1 (programmed death ligand-1) human monoclonal antibody for the treatment of patients with metastatic urothelial carcinoma and for the treatment of patients with unresectable non-small cell lung cancer that has not progressed after chemoradiation.

Development History and FDA Approval Process for Imfinzi

Feb 16, 2018Approval FDA Approves Imfinzi (durvalumab) for Unresectable Stage III Non-Small Cell Lung Cancer
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

Further information

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