FDA approves breakthrough pancreatic cancer drug – an oncologist explains how daraxonrasib nearly doubles survival

The FDA approved daraxonrasib in August 2026 for metastatic pancreatic cancer, a disease with a five-year survival rate around 3%. In a 500-patient Phase 3 trial run by Revolution Medicines, the daily oral drug nearly doubled overall survival compared to chemotherapy, from 6.7 to 13.2 months, while cutting the risk of death by 60%.

The drug works indirectly, binding a protein-folding molecule called cyclophilin A to disable mutated KRAS, a protein once considered too smooth-surfaced for any drug to grab onto. More than 86% of patients experienced a prominent skin rash, along with mouth sores, diarrhea, nausea and vomiting, though patients stayed on treatment longer than those on chemotherapy.

The approval opens the door to real-world data and combination trials pairing daraxonrasib with other drugs to head off resistance.

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