AstraZeneca’s Imfinzi Gets Expanded FDA Approval for Advanced Biliary Tract Cancer

The FDA has granted expanded approval for AstraZeneca’s blockbuster drug Imfinzi (durvalumab) in combination with chemotherapy gemcitabine and cisplatin to treat adults with locally advanced or metastatic biliary tract cancer.

Agency approval was based on results from a phase 3 clinical trial. The major efficacy outcome was overall survival, which was achieved with median overall survival of 12.8 months.

The company said an estimated one in four patients treated with Imfinzi plus chemotherapy were still alive at two years compared to one in 10 treated with chemotherapy alone.

“For the first time, patients in the US with advanced biliary tract cancer have an immunotherapy-based treatment option that meaningfully extends survival and is well-tolerated,” said Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca.