FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma

Regulatory approval: On Aug 26, 2026, the FDA approved daraxonrasib (RASONQUE), a RAS GTPase family inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Approval was supported by the phase 3 RASolute 302 trial, which reported statistically significant improvements in OS, PFS, and ORR versus physician’s choice SOC chemotherapy in both the RAS G12 subgroup and the overall population.

FDA approval: daraxonrasib (RASONQUE) in metastatic pancreatic adenocarcinoma

Type: Regulatory approval (FDA)
Date: 2026-08-26

On August 26, 2026, the US FDA approved daraxonrasib (RASONQUE; Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

Supporting evidence

Efficacy was evaluated in RASolute 302 (NCT06625320), a randomized, open-label, multicenter trial in metastatic pancreatic adenocarcinoma with progression after one prior line. 500 patients were randomized 1:1 to daraxonrasib or physician’s choice standard-of-care chemotherapy.

Primary endpoints were overall survival (OS) and progression-free survival (PFS) (blinded independent central review) assessed in patients with a RAS G12 mutation and in the overall population; ORR was additional.

In the overall population, daraxonrasib vs SOC showed:

  • Median OS: 13.2 vs 6.7 months (HR 0.40, 95% CI 0.30–0.53; p<0.0001)
  • Median PFS: 7.2 vs 3.6 months (HR 0.49, 95% CI 0.38–0.64; p<0.0001)
  • ORR: 30% vs 11% (p<0.0001)

Safety and dosing

Label warnings/precautions include dermatologic/soft tissue toxicity, stomatitis/oral disorders, diarrhea, GI perforation, ILD/pneumonitis, and embryo-fetal toxicity. Recommended dose: 300 mg orally once daily until progression or unacceptable toxicity.

The review used Project Orbis and RTOR; other agencies’ applications may still be under review.

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