August 26, 2026: the U.S. FDA approved daraxonrasib (RASONQUE) for metastatic pancreatic adenocarcinoma, the first RAS-targeted therapy approved for pancreatic cancer. All news →

Indications & Dosing

Approved indication, recommended dose, indications in development and availability

FDA-approved indication (August 26, 2026)

RASONQUE (daraxonrasib) is indicated for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy.

Notably, the indication is not restricted by RAS mutation status. In RASolute 302, both the RAS G12-mutant population and the overall population derived consistent survival benefit, and since more than 90% of pancreatic adenocarcinomas carry a KRAS mutation, the indication covers the great majority of previously treated patients with metastatic disease. Whether molecular testing is needed before treatment should be guided by the current prescribing information and the treating physician.

Recommended dose and administration

Recommended dose300 mg orally once daily
DurationUntil disease progression or unacceptable toxicity
FormulationOral tablets
Dose modificationInterrupt, reduce or permanently discontinue according to the severity of adverse reactions; see the prescribing information for details

For missed doses, administration with or without food, and drug interactions (e.g. strong CYP3A inhibitors/inducers), refer to the FDA-approved prescribing information (USPI).

Indications in development

IndicationStudyPhaseStatus
First-line metastatic pancreatic adenocarcinoma (monotherapy and with chemotherapy)RASolute 303Phase 3Recruiting
Adjuvant therapy after resection of pancreatic adenocarcinomaRASolute 304Phase 3Recruiting
Previously treated RAS-mutant non-small cell lung cancerRASolve 301Phase 3Recruiting
RAS-mutant solid tumors (including colorectal cancer)RMC-6236-001 and combination studiesPhase 1/2Ongoing

Regional availability

  • United States: approved by the FDA on August 26, 2026. Before approval, the FDA had authorised an Expanded Access Protocol allowing eligible patients to receive the drug.
  • European Union, Japan and others: no approval had been publicly announced as of this site's last update; follow Revolution Medicines' official communications for regulatory filing progress.
  • China: as of this site's last update, daraxonrasib had not been approved in mainland China. Clinical trial opportunities can be checked on ClinicalTrials.gov or the Chinese drug trial registry (ChinaDrugTrials).
Important: this page is not treatment advice. All treatment decisions should be made by a qualified oncologist based on the individual patient's situation.
Last updated: September 5, 2026 Content reviewed: September 5, 2026
Content on this site is provided for informational purposes for healthcare professionals and the public. It does not constitute medical advice, diagnosis or treatment. Always follow your physician's guidance and the official prescribing information. Read the full disclaimer