The FDA approved durvalumab (Imfinzi) as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SOC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide), according to AstraZeneca, the agent’s developer.
The approval was based on positive results from the phase III CASPIAN trial, which found that durvalumab in combination SOC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), versus SOC alone.
“The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options,” Dave Fredrickson, executive vice president of the Oncology Business Unit, said in a press release. “Imfinzi is the only immunotherapy to show both a significant survival…