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FDA Approves Amgen’s LUMAKRAS + Vectibix for KRAS G12C-mutated Colorectal Cancer

Approval was based on the pivotal Phase 3 CodeBreaK 300 study.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved Amgen’s 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 tr...

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