Onco-Summaries: Daily Oncology Updates at a Glance
Sep 9
1 min read
07/09/2026
FDA withdraws Krazati’s colorectal cancer indication after KRYSTAL‑10 fails to confirm survival benefit (Ref)
The FDA has finalized the withdrawal of Bristol Myers Squibb’s Krazati (adagrasib; KRAS inhibitor) for colorectal cancer, citing lack of confirmed clinical benefit after the KRYSTAL‑10 Phase III trial failed to meet survival endpoints
Krazati had received accelerated approval in 2024 for KRAS G12C‑mutated advanced/metastatic CRC, based on response data from KRYSTAL‑1
In KRYSTAL‑10, Krazati + cetuximab improved response rates but did not achieve progression‑free survival or overall survival benefit versus chemotherapy
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