Daraxonrasib Approved for Metastatic Pancreatic Cancer

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Key Points

FDA approved daraxonrasib (RASONQUE) on August 26, 2026, for adults with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy or for those not eligible for multiagent systemic therapy.
In the phase 3 RASolute 302 trial, median overall survival reached 13.2 months with daraxonrasib versus 6.7 months with chemotherapy.
Daraxonrasib reduced the risk of death by 60%, and progression-free survival was 7.2 versus 3.6 months.
The approval introduces the first FDA-approved RAS-targeted therapy for metastatic pancreatic cancer.
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Why Does Daraxonrasib Matter in Pancreatic Cancer Treatment?

Daraxonrasib marks a significant change in the treatment landscape for metastatic pancreatic adenocarcinoma, particularly pancreatic ductal adenocarcinoma (PDAC). The FDA approved the oral RAS(ON) multiselective inhibitor after evidence showed longer survival and improved disease control compared with standard chemotherapy.

RAS signaling plays a central role in pancreatic tumor growth. More than 90% of pancreatic cancers harbor activating RAS mutations, making this pathway an important therapeutic target. Daraxonrasib targets RAS proteins in their active state and is designed to inhibit multiple RAS variants rather than a single mutation.

What Did the RASolute 302 Trial Show?

The randomized, open-label phase 3 RASolute 302 trial included 500 patients with metastatic pancreatic adenocarcinoma whose disease progressed after one prior line of systemic therapy. Participants received either daraxonrasib or physician-selected standard-of-care chemotherapy.

Daraxonrasib produced a median overall survival of 13.2 months, compared with 6.7 months with chemotherapy, corresponding to a hazard ratio for death of 0.40. Median progression-free survival was 7.2 months versus 3.6 months, while the objective response rate was 30% versus 11%.

The trial findings, published in the New England Journal of Medicine, demonstrated statistically significant improvements in overall survival, progression-free survival, and objective response rate with daraxonrasib.

What Should Oncology HCPs Know About Daraxonrasib?

For medical oncologists, oncology nurses, gastroenterologists, and other cancer-care professionals, the approval introduces a new targeted treatment option for previously treated metastatic pancreatic cancer. Patient selection, treatment history, RAS biology, and toxicity monitoring will be important considerations in clinical practice.

Common treatment-related adverse events reported in earlier studies included rash, diarrhea, nausea, stomatitis or mucositis, vomiting, and fatigue. The FDA prescribing information also includes warnings for dermatologic and soft-tissue toxicity, stomatitis and oral disorders, diarrhea, gastrointestinal perforation, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

For More Updates, register for the Oncology CME Conferences & Online Courses

For HCPs managing metastatic pancreatic cancer, understanding RAS-directed treatment, molecular testing, efficacy data, and adverse-event management will be increasingly relevant as daraxonrasib enters clinical practice.