FDA granted Breakthrough Therapy designation to elironrasib, a RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
In a move that will have direct impact on approval of cancer drugs, George Francis Tidmarsh, an oncologist and a longtime pharmaceutical executive, was named director of the FDA Center for Drug Evaluation and Research.
