FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.
Erica C NakajimaNicole DreznerXiaoxue LiPallavi S Mishra-KalyaniYajun LiuHong ZhaoYouwei BiJiang LiuAtiqur RahmanEmily WearneIdara OjofeitimiLauren Tesh HotakiDianne SpillmanRichard PazdurJulia A BeaverHarpreet SinghPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2022)
On May 28, 2021, the FDA granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. The approval was based on CodeBreaK 100 (Study 20170543), a dose-escalation and dose-expansion trial in patients with an advanced, KRAS G12C-mutated, solid tumor. The overall response rate (ORR) observed in patients with KRAS G12C-mutated NSCLC treated with sotorasib (n = 124) was 36% [95% confidence interval (CI), 28-45]. The median duration of response was 10.0 months (95% CI, 6.9-not estimable). The most common adverse reactions (≥20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. This is the first approval of a targeted therapy for KRAS G12C-mutated NSCLC. Because of pharmacokinetic data and ORRs of patient cohorts who took sotorasib at lower doses in the dose-escalation portion of CodeBreaK 100, a dose comparison study is being conducted as a post-marketing requirement.
Keyphrases
- wild type
- advanced non small cell lung cancer
- small cell lung cancer
- epidermal growth factor receptor
- drug administration
- chronic pain
- squamous cell carcinoma
- emergency department
- stem cells
- physical activity
- spinal cord
- neuropathic pain
- tyrosine kinase
- machine learning
- spinal cord injury
- oxidative stress
- phase ii
- bone marrow
- drug induced
- big data
- randomized controlled trial
- smoking cessation
- deep learning