On February 15, 2022, the U.S. Food and Drug Administration (FDA) accepted the adagrassib new drug application (NDA) for the treatment of patients with non-small cell lung cancer (NSCLC) with KRAS G12C mutation who had received at least one systemic treatment before. Under the prescription drug user fees act, regulators will decide to apply by December 14, 2022.
Previously, in June 2021, the US FDA has granted adagrassib breakthrough therapy recognition for the treatment of patients with treated non-small cell lung cancer carrying KRAS G12C mutation.
Adagrassib is a powerful oral KRAS G12C inhibitor with high specificity. It irreversibly and selectively binds to KRAS G12C and locks it in an inactive state. It has a long half-life to achieve lasting and continuous KRAS inhibition and lead to deep and lasting antitumor activity.
Common name: adagrassib
Target: KRAS G12C
First approved in the United States: not approved
First approved in China: not approved
It is well known that KRAS mutations are difficult to target and have limited treatment options in history, especially KRAS G12C biomarkers are associated with poor survival outcomes. This time, the FDA’s review of adagrassib’s new drug application marks important progress in providing new and targeted options for KRAS G12C mutant NSCLC patients.
Post time: Apr-11-2022