Imfinzi + Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers

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).

The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the HIMALAYA and TOPAZ-1 Phase III trials, each published in the New England Journal of Medicine Evidence and the POSEIDON Phase III trial, published in the Journal of Clinical Oncology.

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.

See- Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma"-Ghassan K. Abou-Alfa, M.D., M.B.A., George Lau, M.D., F.R.C.P., Masatoshi Kudo, M.D., Ph.D., Stephen L. Chan, M.D.,et al., ,for the HIMALAYA Investigators.Published June 6, 2022. NEJM Evid 2022; 1 (8) DOI:https://doi.org/10.1056/EVIDoa2100070.