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.