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FDA gives AZ the nod for Imfinzi in biliary tract cancer

September 5, 2022

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Imfinzi (durvalumab) has been cleared by the US regulator for the treatment of adult patients with locally advanced or metastatic BTC in combination with gemcitabine/cisplatin chemotherapy, extending the use of Imfinzi beyond lung cancer for the first time.

The approval comes on the back of the TOPAZ-1 trial, which showed that adding Imfinzi to standard first-line chemotherapy for BTC extended overall survival compared to chemo alone, without adding much to the side-effect burden.

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