- 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.
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AstraZeneca's Imfinzi combo gets FDA approval for advanced biliary tract cancer