Revolution Medicines Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to zoldonrasib, a RAS(ON) G12D-selective inhibitor. This designation is for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously been treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. Zoldonrasib is the first investigational drug to receive this designation specifically for targeting the KRAS G12D mutation in NSCLC, highlighting a significant unmet need as there are currently no approved targeted therapies for this mutation. Revolution Medicines is developing zoldonrasib as both a monotherapy and in combination treatments for various cancer types and stages. The Breakthrough Therapy Designation is intended to expedite the development and review of new medicines that address serious conditions and demonstrate substantial improvement over existing treatments.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Revolution Medicines Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9622106) on January 08, 2026, and is solely responsible for the information contained therein.