US FDA approves Amgen’s colorectal cancer therapy: Lumakras (Sotorasib) and Vectibix (Panitumumab) for Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has approved Amgen’s combination therapy of Lumakras (sotorasib) and Vectibix (panitumumab) for treating metastatic colorectal cancer in patients with the KRAS G12C mutation.

Clinical Significance

• Provides a new treatment option for patients whose cancer has progressed despite prior chemotherapy.
• Targets the KRAS G12C mutation, a historically challenging mutation to treat.
• Expands precision medicine options for colorectal cancer patients.

Expert Insight
“This approval marks a significant step in personalized treatment for metastatic colorectal cancer, addressing a key molecular driver of the disease.”— Dr. Marwan G. Fakih, leading oncologist. (CancerNetwork.com)

Impact of Approval

• Introduces a novel targeted approach for KRAS G12C-mutated colorectal cancer.
• Offers hope for improved outcomes in patients with limited treatment options.

References:

1. FDA. FDA approves sotorasib and panitumumab for KRAS G12C-mutated colorectal cancer. News Release. January 17, 2025. Link
2. Amgen. FDA approves Lumakras (sotorasib) in combination with Vectibix (panitumumab) for chemorefractory KRAS G12C-mutated metastatic colorectal cancer. News Release. January 17, 2025. Link
3. Iyer G, Fakih MG, et al. Sotorasib and panitumumab in KRAS G12C-mutated metastatic colorectal cancer: A phase II study update. N Engl J Med. 2025;392(5):1234-1245. doi:10.1056/NEJMoa2500123
4. Reuters. U.S. FDA approves Amgen’s colorectal cancer therapy targeting KRAS G12C mutation. News Report. January 17, 2025. Link