21st Aug 2020 07:37
(Alliance News) - AstraZeneca PLC on Friday said its drug Imfinzi has been approved in Japan to treat extensive-stage small cell lung cancer, an aggressive and fast-growing cancer that usually recurs and progresses quickly.
Imfinzi, the brand name for durvalumab, was approved by Japan's Ministry of Health, Labour & Welfare based on positive results from Astra's phase 3 Caspian trial. The approval is for Imfinzi in combination with etoposide plus platinum chemotherapy.
The Caspian trial showed the drug plus chemotherapy achieved "a statistically significant and clinically meaningful improvement in overall survival" compared to chemotherapy only.
Caspian met the primary endpoint of overall survival with chemotherapy in June 2019, reducing risk of death by 27% versus chemotherapy alone. Median overall survival was 13.0 months, compared to 10.3 months with just chemotherapy.
Around two thirds of small cell lung cancer patients are diagnosed with extensive-stage small cell lung cancer, where the cancer spreads widely through the lung or to other parts of the body.
Dave Fredrickson, executive vice president at Astra's Oncology Business Unit, said: "This approval of Imfinzi provides an important new immunotherapy option in Japan for patients with extensive-stage small cell lung cancer. These patients have an especially poor prognosis, with only 2% surviving beyond five years. Imfinzi, in combination with chemotherapy, delivers a sustained survival benefit and prolonged treatment response with a convenient dosing regimen given every four weeks during maintenance."
By Anna Farley; [email protected]
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