The US Food and Drug Administration (FDA) has approved durvalumab (Imfinzi®) plus chemotherapy as a first-time immunotherapy for the treatment of patients with advanced biliary tract cancer including cholangiocarcinoma.

The approval was based on the results of a phase 3 clinical trial that showed that the combination of durvalumab and the chemotherapy agents gemcitabine and cisplatin reduced the risk of death by 20% compared to chemotherapy only. The combination therapy was also generally well tolerated and the discontinuation rate due to adverse events was the same as for chemotherapy only.

“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,” Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, the makers of durvalumab, said in a press release.

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The chief executive officer of the Cholangiocarcinoma Foundation, Stacie Lindsey, added: “Patients have been waiting a long time for a new, first-line treatment option for biliary tract cancer.”

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Durvalumab is a PD-L1 immune checkpoint inhibitor. It is a monoclonal antibody that binds to PD-L1, thereby inhibiting the binding of the ligand to the PD-1 receptor and releasing the inhibition of immune responses by the tumor cells. It is already approved in the US and other countries for the treatment of some patients with lung cancer and bladder cancer.

Biliary tract cancer is a group of rare and aggressive cancers occurring in the bile ducts and gallbladder. In cholangiocarcinoma, the disease originates from the cells of the biliary tree. 


Imfinzi plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer. News release. AstraZeneca; September 5, 2022.