FDA Approves Imfinzi-Containing Regimen for Biliary Tract Cancer

The Food and Drug Administration approved Imfinzi plus gemcitabine and cisplatin for locally advanced or metastatic biliary tract cancer.

The Food and Drug Administration (FDA) approved Imfinzi (durvalumab) plus gemcitabine and cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer, according to the agency.

The approval is based off findings from the randomized TOPAZ-1 clinical trial, which included 685 patients with locally advanced or metastatic (spread to different parts of the body) biliary tract cancer that had not previously been treated with drugs geared toward advanced disease.

Patients on the trial received either Imfinzi plus gemcitabine plus cisplatin, followed by single-agent Imfinzi or placebo plus gemcitabine and cisplatin, followed by placebo.

In the study population, 56% of patients had cholangiocarcinoma (cancer of the bile ducts connecting the liver, gallbladder and small intestine), 25% had gallbladder cancer and 19% had extrahepatic (outside of the liver) cholangiocarcinoma.

READ MORE: ‘Majority of Patients’ With Cholangiocarcinoma Still Receive Upfront Standard of Care, Despite Recent FDA Drug Approvals

Findings showed that the Imfinzi-containing regimen led to a better average overall survival (time from treatment until death of any cause) of 12.8 months, compared with the placebo-containing regimen, with an average overall survival of 11.5 months.

The group of patients who received Imfinzi also tended to live longer before their disease worsened — an outcome known as progression-free survival. Average progression-free survival for the Imfinzi-containing group was 7.2 months, compared to 5.7 months in the placebo group.

The most common side effects that occurred in 20% or more of patients receiving Imfinzi were: fatigue, nausea, constipation, decreased appetite, abdominal pain, rash and fever.


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