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Amjin announced today that its research KRASG12C inhibitor sotorasib has been awarded the "Breakthrough Therapy Title" by the Drug Review Center (CDE) of china's State Drug Administration (NMPA).
Sotorasib is used to treat patients with local late stage or metastasis non-small cell lung cancer (NSCLC) with KRAS G12C mutations that have received at least one systemic therapy.
this is Amjin's first "breakthrough therapy title" in China.
NSCLC is the most common form of lung cancer, accounting for about 80 to 15 percent of all lung cancer cases worldwide.
KRASG12C is the most common KRAS mutation in NSCLC.
mutation is a biomarker of poor prognostication in patients with NSCLC in China and may be improved by G12C-specific inhibitors.
The breakthrough therapy title underscores the importance of sotorasib, and we look forward to working with Chinese regulators to bring the first targeted therapies to patients with non-small cell lung cancer with KRAS G12C mutations," said David M. Reese, executive vice president of research and development at
Aven."
results from The Year Phase II clinical trial (CodeBreaK 100) support the "breakthrough therapy title", in which sotorasib has long-lasting anti-cancer activity.
