Posted by Michael Wonder on 30 Oct 2023
ArriVent receives FDA breakthrough therapy designation for furmonertinib for first-line treatment of advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
30 October 2023 - ArriVent Biopharma today announced that the US FDA has granted breakthrough therapy designation for furmonertinib for the treatment of patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.
The breakthrough therapy designation was granted based on interim results from FAVOUR trial, a Phase 1b, randomised, open-label, multi-centre clinical trial evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.
