FDA OKs Imfinzi for new indication

The US Food and Drug Administration (FDA) on Friday approved Imfinzi (durvalumab) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC).

Imfinzi, which is marketed globally for the treatment of a variety of lung cancer indications, is already a major product for UK pharma major AstraZeneca (LSE: AZN), pulling in 2021 revenues of $2.41 billion and $695 million in second-quarter 2022.

The FDA said that efficacy was evaluated in TOPAZ-1 (NCT03875235), a randomized, double-blind, placebo-controlled, multiregional trial that enrolled 685 patients with histologically confirmed locally advanced unresectable or metastatic BTC who had not previously received systemic therapy for advanced disease.