Posted by Michael Wonder on 13 Jan 2026
Summit Therapeutics announces submission of biologics license application to US FDA seeking approval for ivonescimab in combination with chemotherapy in second-line (or later) treatment of patients with EGFRm NSCLC
12 January 2026 - Summit Therapeutics today announced that it has submitted a biologics license application to the US FDA seeking approval for ivonescimab, the novel, first in class investigational bispecific antibody, in combination with chemotherapy in second-line or later treatment of patients with epidermal growth factor receptor-mutated locally advanced or metastatic non-squamous non-small cell lung cancer.
The biologics license application submission was based on the overall results of the global Phase III HARMONi trial.
