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priority review for Imfinzi in the USA

(CercleFinance.com) – AstraZeneca announces that its Supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), in combination with chemotherapy, has been accepted by the Food and Drug Administration (FDA) and has undergone priority review in the United States for patients with locally advanced or metastatic bile duct cancer (BTC).

The data showed that Imfinzi plus chemotherapy (gemcitabine plus cisplatin) reduced the risk of death by 20% compared with chemotherapy alone.

“We are working closely with the FDA to potentially set a new standard of care with Imfinzi plus chemotherapy,” says Susan Galbraith, executive vice president of oncology R&D at AstraZeneca.

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