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. 2017 Aug;77(12):1369-1376.
doi: 10.1007/s40265-017-0782-5.

Durvalumab: First Global Approval

Yahiya Y Syed  1
Affiliations

Durvalumab: First Global Approval

Yahiya Y Syed. Drugs. 2017 Aug.

Erratum in

Abstract

Intravenous durvalumab (Imfinzi™; AstraZeneca) is a fully human monoclonal antibody that blocks programmed cell death ligand-1 binding to its receptors (PD-1 and CD80), resulting in enhanced T-cell responses against cancer cells. The US FDA has granted durvalumab accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Durvalumab ± tremelimumab is under phase III clinical trials in urothelial carcinoma, non-small cell lung cancer, small cell lung cancer and head and neck squamous cell carcinoma. The drug is also being evaluated in phase I or II clinical trials in a wide range of solid tumours and haematological malignancies. This article summarizes the milestones in the development of durvalumab leading to this first approval for urothelial carcinoma.

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Figures

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Key milestones in the development of durvalumab. Est estimated completion date, NSCLC non-small cell lung cancer, HNSCC head and neck squamous cell carcinoma, SCLC small cell lung cancer, UC urothelial cancer
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