FDA Grants Breakthrough Therapy Designation to Revolution Medicine’s Zoldonrasib

Revolution Medicines, Inc., has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its experimental drug zoldonrasib. 

The therapy is being developed for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying the KRAS G12D mutation, who have already been treated with anti-PD-1/PD-L1 agents and platinum-based chemotherapy.

Zoldonrasib is a selective inhibitor targeting the active KRAS G12D mutation, a key driver in certain NSCLC tumors. 

The FDA’s decision is supported by data from the Phase 1 RMC-9805-001 study, which demonstrated encouraging tumor responses and a manageable safety profile.

As the first investigational therapy specifically aimed at KRAS G12D, zoldonrasib addresses an area of high unmet need, since no targeted treatments are currently approved for these patients. 

The drug is being evaluated both as a standalone therapy and in combination with other cancer treatments across multiple tumor types.

NSCLC accounts for roughly 80–85% of lung cancers, with the KRAS G12D mutation present in about 4% of patients. 

The Breakthrough Therapy designation is intended to accelerate the development and regulatory review of therapies that show early signs of significant clinical benefit over available options.