FDA gives AstraZeneca approval for Imfinzi
AstraZeneca’s Imfinzi (durvalumab) has been approved by the Food and Drug Administration for the treatment of adult patients with locally advanced or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine plus cisplatin).
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. Approximately 23,000 people in the United States are diagnosed with BTC each year. These patients have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving five years, the company noted.
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“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,” said Aiwu Ruth He, associate professor of medicine and leader of the GI cancer program at the Georgetown Lombardi Comprehensive Cancer Center and Medstar Georgetown University Hospital, and a lead investigator in the TOPAZ-1 Phase III trial.
“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,” he said.
“For the first time, patients in the United States 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, oncology business unit at AstraZeneca. “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.”
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“Patients have been waiting a long time for a new, first-line treatment option for biliary tract cancer,” said Stacie Lindsey, CEO of the Cholangiocarcinoma Foundation. “The foundation congratulates AstraZeneca for engaging in rare cancer research, which impacts patients and families nationwide. We are especially grateful to the patients who participated in this trial, making it possible for the broader rare disease community to benefit from this treatment.”