AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for its monoclonal antibody - Imfinzi (durvalumab).
The decision is for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC), and was allegedly based on positive results from the Phase III CASPIAN trial, which found that the drug in combination with the current standard of care (etoposide with either cisplatin or carboplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival.
More specifically, the median overall survival for Imfinzi plus chemotherapy was found to be 13.0 months vs. 10.3 months for just standard of care. Further, the 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. The trial is being conducted in more than 200 centres across 23 countries, including the US, Europe, South America, Asia and the Middle East.
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths. The disease is broadly split into non-small cell lung cancer and small cell lung cancer, with about 15% classified as small cell lung cancer.