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AstraZeneca: priority review for Imfinzi in US

(CercleFinance.com) - AstraZeneca has announced that its supplemental biologics license application (sBLA) for Imfinzi (durvalumab), in combination with chemotherapy, has been accepted by the FDA for priority review in the US for patients with locally advanced or metastatic biliary tract cancer (BTC).


Data shows that Imfinzi plus chemotherapy (gemcitabine plus cisplatin) reduced the risk of death by 20% compared to chemotherapy alone.

The group said that it is working closely with the FDA to potentially set a new standard of care with Imfinzi plus chemotherapy.


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