The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s (NASDAQ: AMGN) Lumakras (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The regulator has requested an additional confirmatory study, which Amgen intends to complete by 2028.
Currently, Lumakras retains an accelerated approval status in the US, granted in 2021 for the same indication. This initial approval was based on overall response rate (ORR) and duration of response (DOR) data.- Flcube.com
