Revolution Medicines, Inc. (RVMD) on Thursday said the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to zoldonrasib for the treatment of adult patients with KRAS G12D-mutated non-small cell lung cancer (NSCLC) who have previously received anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.
The designation is based on data from the monotherapy cohort of a Phase 1 study evaluating zoldonrasib in patients with advanced KRAS G12D solid tumors. Results demonstrated a robust clinical profile, showing encouraging antitumor activity along with acceptable safety and tolerability.
The company is assessing zoldonrasib both as a monotherapy and in combination therapies across multiple tumor types and lines of treatment.
Revolution Medicines shares were down more than 8% in pre-market trading after closing at $102.71, up 28.63%.
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