As researchers consider using circulating tumor DNA as an endpoint in clinical trials to evaluate drug efficacy, a collaboration led by Friends of Cancer Research is creating the evidentiary roadmap for the use of ctDNA in regulatory decisions.
FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.
