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Updated: Oct 10, 2025
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FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC
Erica C Nakajima1, Nicole Drezner1, Xiaoxue Li1
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Summary
Sotorasib is the first targeted therapy approved for advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. This breakthrough offers a new treatment option for patients who have not responded to prior therapies.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- Non-small cell lung cancer (NSCLC) is a leading cause of cancer death.
- The Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation is present in a subset of NSCLC patients.
- Targeted therapies have shown promise in treating specific cancer mutations.
Purpose of the Study:
- To evaluate the efficacy and safety of sotorasib for advanced NSCLC with KRAS G12C mutation.
- To support the accelerated approval of sotorasib by the FDA.
- To investigate the overall response rate and duration of response in treated patients.
Main Methods:
- CodeBreaK 100 (Study 20170543) was a dose-escalation and dose-expansion trial.
- Patients had advanced NSCLC with a KRAS G12C mutation and received prior systemic therapy.
- Efficacy was assessed by overall response rate (ORR) and duration of response (DOR).
Main Results:
- Sotorasib demonstrated an ORR of 36% (95% CI, 28-45) in patients with KRAS G12C-mutated NSCLC.
- The median duration of response was 10.0 months (95% CI, 6.9-not estimable).
- Common adverse reactions included diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
Conclusions:
- Sotorasib is the first targeted therapy approved for KRAS G12C-mutated NSCLC.
- The drug provides a new treatment option for patients with this specific genetic mutation.
- Post-marketing studies are ongoing to further evaluate dosing and efficacy.
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