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Japan’s Ministry of Health, Labour, and Welfare approved AstraZeneca’s (NASDAQ:AZN) immunotherapies Imfinzi and Imjudo to treat certain types of liver and lung cancers and Imfinzi to treat biliary tract and liver cancers.
The approvals allow Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) to treat adult patients with unresectable hepatocellular carcinoma (HCC) (a type of liver cancer) and to treat adult patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) in combination with chemotherapy.
Imfinzi was also authorized for treating adult patients with unresectable HCC as monotherapy and to treat adult patients with curatively unresectable biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).
The approvals were backed by data from the phase 3 trials called HIMALAYA, TOPAZ-1 and POSEIDON.
“With these approvals for Imfinzi and Imjudo, patients in Japan can now be treated with novel immunotherapy-based treatment regimens that have demonstrated significant survival benefits across three complex cancers with poor prognoses,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca.
The Imjudo/Imfinzi combo is already approved in the U.S. to treat certain types of liver and lung cancers.
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