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FDA Withdraws Adagrasib/Cetuximab Approval in KRAS G12C-Mutated CRC
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Biotech
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United States
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Fusion42 · 8 September 2026 · Fusion42 review
The FDA has withdrawn accelerated approval for the combination of adagrasib and cetuximab for KRAS G12C-mutated colorectal cancer after the KRYSTAL-10 trial failed to demonstrate improved survival outcomes.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
You face a major market exit in colorectal cancer treatment as FDA pulls your drug combo's approval. Redirect focus to alternative KRAS G12C therapies or indications where regulatory status remains intact.
◆ Coverage
1 source · 8 Sep 2026
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Biotechfda-withdrawaladagrasibcetuximabkras-g12ccolorectal-cancer