Posted by Michael Wonder on 30 Nov 2019
Imfinzi granted FDA priority review for the treatment of patients with extensive-stage small cell lung cancer
29 November 2019 - AstraZeneca today announced that the US FDA has accepted a supplemental biologics license application and granted priority review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer.
A Prescription Drug User Fee Act date is set for the first quarter of 2020.
The application 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) demonstrated a statistically significant and clinically meaningful improvement in overall survival vs. SoC.
