ARTICLE | Product Development
Amgen’s Lumakras approval marks first of more milestones to come in KRAS story
Amgen is the first to market with a KRAS inhibitor, but there’s still room to expand into new indications, combinations and mutations
May 28, 2021 7:06 PM UTC
FDA’s approval of the first KRAS inhibitor almost three months before its PDUFA date caps off the breakneck speed of Amgen’s clinical development program for the molecule, and reflects the impact the KRAS G12C inhibitor could have on patients.
Lumakras sotorasib received accelerated approval as a monotherapy to treat patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), making it the first targeted therapy approved for NSCLC patients with the common mutation, and the first KRAS inhibitor overall to reach the finish line. ...