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FDA Approves Amgen's LUMAKRAS® (Sotorasib) in Combination With Vectibix® (Panitumumab) for the Treatment of Adult Patients With KRAS G12C-Mutated Metastatic Colorectal Cancer

January 21, 2025 10:38 AM | Katy Monaco (Administrator)

FDA has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC).

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