AstraZeneca: Imfinzi + Imjudo Approved In Japan For Advanced Liver, Biliary Tract And Lung Cancers

British drug major AstraZeneca Plc. (AZN.L,AZN) announced Wednesday that its immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) have been approved in Japan for the treatment of three cancer types, such as advanced liver, biliary tract and lung cancers.

Imfinzi plus Imjudo has been approved for advanced liver and non-small cell lung cancers, and Imfinzi has been approved for unresectable biliary tract and liver cancers.

The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare were based on significant survival benefits in HIMALAYA, POSEIDON and TOPAZ-1 Phase III trials.

These positive results from the HIMALAYA and TOPAZ-1 Phase III trials each were published in the New England Journal of Medicine Evidence and the POSEIDON Phase III trial was published in the Journal of Clinical Oncology.

The company noted the approvals authorise Imfinzi in combination with Imjudo for the treatment of adult patients with unresectable hepatocellular carcinoma or HCC and for the treatment of adult patients with unresectable, advanced or recurrent non-small cell lung cancer or 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 or BTC in combination with chemotherapy (gemcitabine plus cisplatin).

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said, "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."

The company noted that regulatory applications for Imfinzi and Imjudo are currently under review in the EU and several other countries based on the HIMALAYA, TOPAZ-1 and POSEIDON results.

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