The FDA accepted a supplemental Biologics License Application for durvalumab and granted it priority review for the treatment of patients with previously untreated extensive-stage small cell lung cancer, according to a manufacturer press release.
The FDA based the designation on results from the phase 3 CASPIAN trial, published earlier this year in The Lancet. The trial is being conducted at more than 200 centers across 23 countries.
Treatment vial. Source: Getty
The CASPIAN trial compared durvalumab plus standard-of-care chemotherapy (etoposide with either cisplatin or carboplatin) with chemotherapy alone. The treatment combination resulted in statistically significant and clinically meaningful improved overall survival. The risk of death was reduced by 27% for patients treated with durvalumab plus chemotherapy, with a median overall survival of 13 months compared with 10.3 months with chemotherapy alone (HR = 0.73).
Survival rates at 18 months appeared better with the treatment combination (33.9% vs. 24.7%).
The trial reported that safety was consistent with the known profiles of all drugs in the combination therapy.
Durvalumab is currently approved for the treatment of unresectable, stage III non-small cell lung cancer.