Sotorasibu (AMG 510) latest clinical research and drug trends in 2025

In January 2025 January, the United StatesFDA approved sotorasiib and anti-EGFR monoclonal antibodies Panitumumab (Panitumumab, trade name: Vectibix) is used in combination to treat KRAS G12C mutated metastatic colorectal cancer (mCRC). The approval was based on results from the CodeBreaK 300 study, which showed that the median progression-free survival (PFS) in the combination arm was 5.6 months, which was significantly better than the 2.0 months with standard treatment. This combination therapy provides a new treatment option for patients with KRAS G12C mutated colorectal cancer.

In the CodeBreaK 200 study, sotoraxib was compared with the chemotherapy drug docetaxel (Docetaxel) to evaluate its efficacy in KRAS Efficacy in patients with G12Cmutated non-small cell lung cancer (NSCLC). Preliminary results show that sotorasiib has advantages in objective response rate (ORR) and disease control rate (DCR), but the FDA has not yet fully approved the therapy and further data support is still needed.

In 2021, sotorasiib received accelerated approval from the FDA for the treatment of patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer. The approval is based on results from the CodeBreaK 100 study, which showed that sotoraxib had favorable efficacy and tolerability in this patient population.

As of2025, sotorasiib has been approved in more than 50 countries around the world for KRAS G12CMutated non-small cell lung cancer patients. In China, the marketing process for sotoraxib is still ongoing and is expected to be approved in the future. Patients should be under the guidance of a doctor when using sotoraxib to ensure efficacy and safety.

Reference link:https://www.drugs.com