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FDA Approves Amgen Treatment For Pretreated Colorectal Cancer With Certain Mutation - Amgen (NASDAQ:AMGN)

  • The Food and Drug Administration approved Amgen Inc.'s Lumakras in combination with Vectibix for KRASG12C-mutated metastatic colorectal cancer, which has received prior chemotherapy.
  • The approval is based on the Phase 3 Codebreak 300 study, showing that Lumakras plus Vectibix provides superior progression-free survival compared to standard-of-care.
  • The study showed an improved median progression-free survival of 5.6 months for Lumakras plus Vectibix, compared to 2 months on the investigator's choice of care.
  • The KRASG12C mutation is present in approximately 3-5% of colorectal cancers, highlighting the targeted nature of this treatment.
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