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FDA Grants Durvalumab Orphan Drug Status in Small Cell Lung Cancer

Gina Columbus @ginacolumbusonc
Published: Friday, Jul 12, 2019

Jose Baselga, MD

José Baselga, MD

The FDA has granted an Orphan Drug Designation to durvalumab (Imfinzi) for the treatment of patients with small cell lung cancer (SCLC), according to AstraZeneca, the developer of the PD-L1 inhibitor.1

Durvalumab is currently approved for the treatment of patients with unresectable, stage III non–small cell lung cancer following chemotherapy and radiation therapy in more than 45 countries including the United States, European Union, and Japan.


  1. Imfinzi Granted US Orphan Drug Designation for Small Cell lung cancer. AstraZeneca. Published July 12, 2019. Accessed July 12, 2019.
  2. Imfinzi Improves Overall Survival at Interim Analysis in the Phase III CASPIAN Trial in 1st-Line Extensive-Stage Small Cell Lung Cancer. AstraZeneca. Published June 27, 2019. Accessed June 27, 2019.

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