Posted by Michael Wonder on 09 Dec 2020
Amgen's sotorasib granted breakthrough therapy designation for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
8 December 2020 - Sotorasib also accepted into FDA's Real-Time Oncology Review pilot program.
Amgen today announced that the U.S. FDA granted breakthrough therapy designation for its investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.
