Eli Lilly Wins USFDA Breakthrough for Olomorasib in Lung Cancer Therapy

Eli Lilly and Company has been given the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for olomorasib combined with anti-PD-1 therapy Keytruda (pembrolizumab) as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation and PD-L1 expression of 50%. 

Olomorasib is a next-generation, highly selective KRAS G12C inhibitor that has demonstrated central nervous system activity. The use of this designation is to facilitate the drug’s development and the drug’s review by the FDA after some initial clinical data showing the drug’s efficacy compared to the already existing therapies.

“The breakthrough therapy designation is just one of many indicators of olomorasib’s potential to become a major therapeutic innovation for patients suffering from the KRAS G12C-mutant NSCLC disease, especially as immunotherapy is usually the first-line treatment,” said Dr. David Hyman, Chief Medical Officer, Lilly. He also mentioned the company’s commitment to the expansion of studies to more patients with longer follow-up in the Phase 3 SUNRAY-01 and SUNRAY-02 ongoing studies.

Also Read: Takeda Pharma Plans to Launch Clinical Trials in India Soon

The FDA’s decision has support from the results of the Phase 1/2 LOXO-RAS-20001 trial and the dose optimization segment of the Phase 3 SUNRAY-01 trial. Revisions to the results will be presented at the 2025 World Conference on Lung Cancer (WCLC) in Barcelona.

Lilly has two oral presentations at WCLC that detail the efficacy and safety data integrated analyses for patients with KRAS G12C-mutant NSCLC treated with olomorasib in combination with Keytruda, including chemoimmunotherapy cohorts.