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FDA Withdraws Indication for Adagrasib Plus Cetuximab in Previously Treated, KRAS G12C ...
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Fusion42 · 14 September 2026 · Fusion42 review
The FDA has withdrawn the accelerated approval indication for adagrasib plus cetuximab in treating previously treated KRAS G12C-mutated metastatic colorectal cancer after the phase 3 KRYSTAL-10 trial failed to show significant improvement in overall or progression-free survival compared to chemotherapy.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 8 Sep 2026 and 14 Sep 2026.
◆ ◆ The Wire takeaway
You must rethink market strategies relying on adagrasib plus cetuximab for KRAS G12C colorectal cancer in the US as FDA withdrawal closes this treatment path. The move opens opportunity for competitors or alternative therapies to fill this unmet clinical need.
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2 sources · first reported 8 Sep 2026 · latest 14 Sep 2026
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