US FDA Approves Amgen's Lumakras-Vectibix Combo for KRAS G12C-Mutated mCRC

Amgen announced that the US Food and Drug Administration (FDA) has granted approval for Lumakras (sotorasib) in conjunction with Vectibix (panitumumab) for treating adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) confirmed by an FDA-approved test, who have previously undergone chemotherapy based on fluoropyrimidine, oxaliplatin, and irinotecan.

Approval is founded on the crucial phase 3 CodeBreaK 300 trial, which indicated that Lumakras combined with Vectibix is the first and sole targeted treatment pairing for chemorefractory KRAS G12C-mutated mCRC that exhibits improved progression-free survival (PFS) when compared to the evaluated standard-of-care (SOC).

"Colorectal cancer is the third leading cause of cancer-related deaths in the United States, and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "Lumakras plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."

"There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer," said Michael Sapienza, chief executive officer of the Colorectal Cancer Alliance. "This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease."