Regulators in the US have accepted AstraZeneca’s supplemental Biologics License Application (sBLA) and granted Priority Review for 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 despite initial response to platinum-based chemotherapy.
The sBLA was based on positive results from the Phase III CASPIAN trial published in The Lancet.
Results showed 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 (OS) vs. SoC.
The risk of death was reduced by 27% with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Results showed an estimated 33.9% of patients were alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients receiving SoC.
A Prescription Drug User Fee Act date is set for the first quarter of 2020.