Nov 29, 2019:US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC).
SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly even with initial response to platinum-based chemotherapy.A Prescription Drug User Fee Act date is set for the first quarter of 2020.The sBLA was based on positive results from the Phase III CASPIAN trial published in The Lancet, showing Imfinzi in combination with standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) established a statistically considerable and clinically meaningful improvement in overall survival (OS) vs. SoC.
Death rate was reduced by 27% with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Result data showed an approximate of 33.9% of patients were alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients receiving SoC. https://www.astrazeneca.com/media-centre/press-releases/2019/imfinzi-granted-fda-priority-review-for-the-treatment-of-patients-with-extensive-stage-small-cell-lung-cancer.html
