Amgen submitted a new drug application for KRAS G12C inhibitor for the treatment of non-small cell lung cancer

KRAS G12C is the most common KRAS mutation in NSCLC.
, about 13 percent of NSCLC patients in the U.S. carry KRAS G12C mutations.
treatment in patients with KRAS G12C-driven NSCLC has a high level of unsolved needs and poor prognostication, no KRAS G12C targeted therapy has been approved.
, developed by Amgen, is a once-a-day oral KRAS G12C inhibitor.
is currently being studied in a wide range of clinical projects to explore the effectiveness of 10 combination therapies.
in just over two years, the sotorasib clinical program has treated more than 600 patients in 13 tumor types.
application was supported by positive Phase 2 clinical trial results for patients with localized late stage or metastasis NSCLC.
registered patients who had been treated with chemotherapy and/or immunotherapy, progressed in cancer.
study, sotorasib therapy provides long-lasting anti-cancer activity with greater benefits than risks.
results will be announced at the International Association for Lung Cancer Research (IASLC) World Lung Cancer Congress 2020 (WCLC) in January 2021.
clinical trial data published in the New England Journal of Medicine in September showed that in NSCLC patients, sotorasib had an objective mitigation rate (ORR) of 32.2% and a disease control rate of 88.1% (DCR), with a medium progression-free survival of 6.3 months.
: s1. Amgen Submits Sotorasib New Drug Application To U.S. FDA For Advanced Or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation. Retrieved 2020-12-16, from Source: Supplied