AstraZeneca PLC said Monday that its Imfinzi and Imjudo combinations have been recommended for marketing authorization in the European Union for advanced liver and lung cancer.
The Anglo-Swedish pharma giant
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said the Committee for Medicinal Products for Human Use of the European Medicines Agency based its opinion on results from the Himalaya Phase 3 trial, and results from the Poseidon Phase 3 trial.
The company said concurrent positive opinions recommend authorizing Imfinzi in combination with Imjudo for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma, or HCC. It also recommends 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 company said Imjudo plus Imfinzi was approved in the U.S. in October for the treatment of adults with unresectable HCC, and that in November Imjudo plus Imfinzi in combination with platinum-based chemotherapy was approved in the U.S. for the treatment of adults with metastatic non-small cell lung cancer.
Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com