Amgen AMGN announced that the FDA has approved its KRAS inhibitor, Lumakras (sotorasib), in combination with its anti-EGFR antibody, Vectibix (panitumumab), for treating KRAS G12C-mutated metastatic colorectal cancer (mCRC).

Approval is based on data from the Phase III CodeBreaK 300 trial, which demonstrated that treatment with Lumakras and Vectibix significantly improved progression-free survival in patients with KRAS G12C-mutated metastatic colorectal cancer.

The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients with a specific gene mutation.

The U.S. Food and Drug Administration (FDA) has approved Amgen’s (NASDAQ:AMGN) KRASG12C inhibitor Lumakras as part of a combination regimen for adults with metastatic colorectal cancer (mCRC) whose tumors harbor an abnormal gene known as KRAS G12C.