Eli Lilly's Investigational Oncology Drug Olomorasib Receives FDA Orphan Drug Designation for KRAS G12C-Mutated NSCLC

According to the Zhidian Finance APP,The U.S. Food and Drug Administration (FDA) has granted Eli Lilly and Company (LLY.US) orphan drug designation for its investigational drug Olomorasib for the treatment of KRAS G12C-mutated non-small cell lung cancer (NSCLC).It is reported that the drug is currently in phase III clinical trials for the aforementioned indications. It is being evaluated as a first-line treatment for patients with advanced non-small cell lung cancer harboring the KRAS G12C mutation, used in combination with Keytruda (pembrolizumab), with or without chemotherapy.

Last August, data presented by Eli Lilly at the 2024 ASCO Breakthrough Summit hosted by the American Society of Clinical Oncology (ASCO) showed that Olomorasib (50 or 100 mg BID) in combination with Keytruda demonstrated favorable safety and antitumor activity in patients with KRAS G12C-mutated advanced non-small cell lung cancer, supporting further development for first-line non-small cell lung cancer.