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Imfinzi, Imjudo approved in Japan for 3 cancers
Imfinzi, Imjudo approved in Japan for 3 cancers.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 28 December 2022 07:00 GMT\n \n \n \n \n \n \n \n \n Imfinzi\n \n \n plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers\n \n \n \n \n \n \n \n \n \n Approvals based on significant survival benefits in\n \n \n \n \n HIMALAYA, POSEIDON and TOPAZ-1 Phase III trials\n \n \n \n \n \n \n \n \n AstraZeneca's immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) have been approved in Japan for the treatment of three cancer types: advanced liver, biliary tract and lung.\n \n \n \n \n \n The approvals authorise Imfinzi in combination with Imjudo for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of adult patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) in combination with chemotherapy. Imfinzi was also authorised for the treatment of adult patients with unresectable HCC as monotherapy and for the treatment of adult patients with curatively unresectable biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).\n \n \n \n \n \n The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the\n \n HIMALAYA\n \n and\n \n TOPAZ-1\n \n Phase III trials, each published in the New England Journal of Medicine Evidence and the\n \n POSEIDON\n \n Phase III trial, published in the Journal of Clinical Oncology.\n \n \n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: \"Japan has one of the highest rates of diagnosis for liver and biliary tract cancers in the world, and lung cancer remains the country's leading cause of cancer death. 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.\"\n \n \n \n \n \n \n Imfinzi\n \n \n and Imjudo approved in liver cancer\n \n \n The approval of Imfinzi in combination with Imjudo for the treatment of unresectable HCC brings the first dual immunotherapy treatment regimen to patients in Japan. The approval is based on results from the HIMALAYA Phase III trial,...