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Revolution Medicines' Zoldonrasib Gets FDA Breakthrough Therapy Status For KRAS G12D-mutated NSCLC

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

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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