In January 2025, the U.S. Food and Drug Administration (FDA) approved Amgen’s combination therapy of Lumakras (sotorasib) with Vectibix (panitumumab) for treating adult patients with metastatic colorectal cancer (mCRC) harboring the KRAS G12C mutation. This approval is specifically for patients whose cancer has progressed despite prior chemotherapy treatments, including fluoropyrimidine, oxaliplatin, and irinotecan. The decision was based on a pivotal Phase 3 study demonstrating that the combination therapy extended progression-free survival to 5.6 months, compared to two months with standard care.
The KRAS G12C mutation occurs in approximately 3% to 5% of colorectal cancers and has historically been challenging to target therapeutically. Lumakras is designed to inhibit the mutated KRAS protein, while Vectibix targets the epidermal growth factor receptor (EGFR), both contributing to tumor growth suppression. Concurrently, the FDA approved Qiagen’s companion diagnostic device to identify patients eligible for this treatment combination, enhancing the precision of therapy selection. Click for More Details
