Is Sotolaxib (AMG510) included in medical insurance?

Sotorasiib (AMG510), which received accelerated approval in the U.S. in 2019 for adults with KRAS G12C-mutated non-small cell lung cancer ((NSCLC)), is still under evaluation for other forms of KRAS-containing G12C mutated cancer. Sotoraxib is available in 120 mg and 320 mg tablets under the trade name Lumakras. Since the original drug of sotoraxib has not been approved by the National Medical Products Administration, it has not been included in medical insurance.

Sotorasiib specifically and irreversibly inhibits KRAS G12C and has been approved in more than 40 countries for the treatment of adult patients with KRAS G12C mutated advanced non-small cell lung cancer after prior systemic therapy. In the CodeBreaK phase 100 study, the objective response rate (ORR) of sotoraxib in KRAS G12C mutated advanced non-small cell lung cancer was 37%, the median duration of response (DOR) was 11.1 months, the median PFS was 6.8 months, the median OS was 12.5 months, and the safety was controllable.

The results of this analysis of more than2 years of follow-up data showed that nearly a quarter of patients with previously treated advanced KRAS and G12C mutated non-small cell lung cancer who received sotorasiib achieved long-term benefits with almost no late treatment-related toxicity. These reactions include but are not limited to diarrhea, nausea, vomiting, abdominal pain, fatigue, myalgia, arthralgia, cough, dyspnea, and abnormal changes in hematological indicators. These side effects may cause some patients to need to adjust the dosage of the drug or temporarily discontinue the drug. This supports not only its use in this therapeutic setting, but also other studies investigating its therapeutic role in earlier treatments.