AstraZeneca's Imfinzi combo gets FDA approval for advanced biliary tract cancer
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The U.S. Food and Drug Administration (FDA) approved AstraZeneca's (NASDAQ:AZN) Imfinzi (durvalumab), in combination with chemotherapy (gemcitabine plus cisplatin) to treat adult patients with locally advanced or metastatic biliary tract cancer (BTC).
The approval was backed by data from a phase 3 trial called TOPAZ-1, the British drugmaker said in a Sept. 5 press release.

The company said Imfinzi plus chemotherapy was approved in the U.S. as the first immunotherapy regimen for patients with advanced BTC. Imfinzi had received priority review from the FDA.
AstraZeneca's added that Imfinzi's regulatory applications are also currently under review in Europe, Japan and certain other countries based on the TOPAZ-1 results.
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. About 23K people in the U.S. are diagnosed with BTC each year, the company noted.