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.

The CodeBreaK 300 results demonstrated that Lumakras 960 mg daily plus Vectibix (n=53) showed an improved median progression-free survival (PFS) of 5.6 months compared to 2 months on the investigator’s choice of care (n=54).

The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival,

Lumakras (sotorasib) and Vectibix (panitumumab) have been authorised for use in adults with KRAS G12C-mutated metastatic colorectal cancer who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

The FDA has approved Lumakras with Vectibix for adults with KRAS G12C-mutated metastatic colorectal cancer who received chemotherapy.

Lumakras, primarily known for lung cancer treatment, became the first FDA-approved KRASG12C inhibitor in 2021 for non-small cell lung cancer. Amgen continues expanding its use, aiming to address cancers driven by the same genetic mutation.

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. Amgen's Lumakras in combination with Vectibix was approved to treat adult patients whose cancer has spread to other parts of the body despite receiving chemotherapy,