AstraZeneca’s Imfinzi plus Imjudo recommended for EU approval
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AstraZeneca said on Monday that its Imfinzi (durvalumab) and Imjudo (tremelimumab) combinations have been recommended for marketing authorisation in the European Union for advanced liver and lung cancers.
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The concurrent positive opinions recommend authorising Imfinzi in combination with Imjudo for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma. They also recommend Imfinzi in combination with Imjudo and platinum-based chemotherapy for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinions on results from the Himalaya Phase III trial and the Poseidon Phase III trial.
Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said: "Patients in Europe diagnosed with these advanced cancers urgently need treatment combinations that can help them live longer.
"If approved, these Imjudo and Imfinzi combinations will provide patients with novel options that harness the potential long-term survival benefits seen with CTLA-4 inhibition."