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Imfinzi FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Apr 22, 2020.

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, Small Cell Lung Cancer

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:

  • for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who:
    • have disease progression during or following platinum-containing chemotherapy.
    • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.
    This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
  • in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Development Timeline for Imfinzi

Nov 20, 2020Approval Imfinzi Approved in the US for Less-Frequent, Fixed-Dose Use
Mar 30, 2020Approval Imfinzi (durvalumab) Approved in the US for Extensive-Stage Small Cell Lung Cancer
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

Further information

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