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FDA Grants Durvalumab Priority Review for Frontline Small Cell Lung Cancer

Jason M. Broderick @jasoncology
Published: Monday, Dec 02, 2019

The FDA has granted a priority review designation to a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).1

Durvalumab is approved by the FDA for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer who have not progressed following chemoradiotherapy. The PD-L1 inhibitor also has an FDA-approved indication for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

References

  1. Imfinzi granted FDA Priority Review for the treatment of patients with extensive-stage small cell lung cancer. Published November 29, 2019. https://bit.ly/2ODJCWt. Accessed December 2, 2019.
  2. L. Paz-Ares, Y. Chen, N. Reinmuth, et al. Overall survival with durvalumab plus etoposide-platinum in first-line extensive-stage SCLC: results from the CASPIAN study. Presented at: IASLC 20th World Conference on Lung Cancer; September 7-10, 2019; Barcelona, Spain. Abstract OA02.02.

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