Revolution Medicines announces FDA BTD to zoldonrasib

Revolution Medicines (RVMD) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to zoldonrasib, a RAS(ON) G12D-selective inhibitor, for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. The Breakthrough Therapy Designation is based on data from the monotherapy cohort of the Phase 1 RMC-9805-001 clinical trial evaluating zoldonrasib in patients with advanced KRAS G12D solid tumors. Results from the monotherapy cohort of the trial have demonstrated a robust clinical profile, including encouraging antitumor activity and acceptable safety and tolerability.