The activity of sotorasib in patients with KRASG12C-mutated non-small-cell lung cancer (NSCLC) has been demonstrated, which led to Accelerated Approval by the FDA in May 2021 (ref. However, the extent of the efficacy, optimal therapeutic sequencing and conditions under which this drug could receive full regulatory approval remain unclear. The pharmaceutical industry is following the sotorasib saga with great interest because it is the first KRAS G12C inhibitor to receive approval. Differences among KRAS G12C inhibitors that are clinically meaningful enough to be detectable in crosstrial comparisons are very unlikely to emerge. In this regard, the data disclosed at the meeting of the FDA Oncologic Drugs Advisory Committee held on 5 October 2023 (refs.

Source: Washington Post January 30, 2024 13:08 UTC