Global News

AstraZeneca’s IMFINZI (durvulumab) has been approved in the US for the treament of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).

This FDA approval was based on the results from the TOPAZ-1 Phase III trial. In an interim analysis of TOPAZ-1, IMFINZI plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone.

BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. Roughly 23,000 peope in the US are diagnosed with BTC each year. These patients have a poor prognosis, with only approximately 5-15% of patients with BTC surviving five years.

Aiwu Ruth He, MD, PhD, Associate Professor of Medicine, and a lead investigator in the TOPAZ-1 Phase III trial, said: "This approval represents a major step forward for patients with advanced biliary tract cancer, who urgently need new, well-tolerated, and effective treatment options after more than a decade of limited innovation. The combination of durvalumab and chemotherapy should become a new standard of care in this setting, having demonstrated significantly improved survival for these patients who have historically faced a poor prognosis."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "For the first time, patients in the US with advanced biliary tract cancer have an immunotherapybased treatment option that meaningfully extends survival and is well-tolerated. This approval for IMFINZI and chemotherapy advances our ambition to challenge treatment expectations and transform care for patients with gastrointestinal cancers with high unmet need."