[Perspectives] The fate of sotorasib: a regulatory failure potentially harming patients

Sotorasib was the first approved KRAS inhibitor granted marketing authorisation by the US Food and Drug administration (FDA) by use of the accelerated approval pathway for patients with advanced non-small-cell lung cancer (NSCLC) with the KRASG12C mutation. The drug targets a subset of mutations in KRAS—an oncogene considered undruggable for decades—that occur in 14% of patients with NSCLC.2