FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer Following Landmark Clinical Trial Led by Dana-Farber

he U.S. Food and Drug Administration (FDA) has approved daraxonrasib, an oral multi-selective RAS(ON) inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.

By
August 26, 2026
5 min

Dana-Farber

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Daraxonrasib is the first approved RAS-targeted therapy for metastatic pancreatic cancer, based on the RASolute 302 trial.
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The FDA approval was supported by evidence showing daraxonrasib nearly doubled median overall survival compared to chemotherapy.
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In the RASolute 302 trial, median overall survival was 13.2 months for daraxonrasib versus 6.7 months for chemotherapy.
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Patients receiving daraxonrasib had a 60% reduced risk of death and a median progression-free survival of 7.2 months.
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The most common side effects of daraxonrasib included rash, mouth inflammation, nausea, and diarrhea, with no new safety signals reported.

FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer Following Landmark Clinical Trial Led by Dana-Farber

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Original Source(s)

FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer Following Landmark Clinical Trial Led by Dana-Farber

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