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AstraZeneca: Imfinzi + Imjudo approved in Japan for advanced liver, bile duct and lung cancers

ProDentim


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

Concurrent approvals from the Japanese Ministry of Health, Labor and Welfare were based on significant survival benefits in the Phase III HIMALAYA, POSEIDON and TOPAZ-1 trials.

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

The company noted that the approvals authorize Imfinzi in combination with Imjudo for the treatment of adult patients with hepatocellular carcinoma or unresectable HCC and for the treatment of adult patients with non-small cell lung cancer or unresectable, advanced or recurrent NSCLC in association with chemotherapy.

Imfinzi has also been authorized for the treatment of adult patients with unresectable HCC as monotherapy and for the treatment of adult patients with curatively unresectable bile duct cancer or BTC in combination with chemotherapy (gemcitabine plus cisplatin).

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, said, “With these approvals for Imfinzi and Imjudo, patients in Japan can now be treated with new immunotherapy-based treatment regimens. which demonstrated significant survival benefits for three complex cancers with poor prognosis.”

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

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