FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma

On August 26, 2026, the Food and Drug Administration 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.

Full prescribing information for RASONQUE will be posted on Drugs@FDA.

Efficacy and Safety

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

Major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) as assessed by blinded independent central review in patients with a RAS G12 mutation and in the overall population. ORR was an additional outcome measure. The trial demonstrated a statistically significant improvement in OS, PFS, and ORR for patients treated with daraxonrasib compared to SOC chemotherapy, both in the RAS G12 population and in the overall population.

In the overall population, median OS was 13.2 months (95% CI: 10.0, not estimable [NE]) in the daraxonrasib arm and 6.7 months (95% CI: 5.8, 8.0) in the SOC arm (Hazard ratio 0.40 [95% CI: 0.30, 0.53]; p-value <0.0001). Median PFS was 7.2 months (95% CI: 5.7, 7.5) in the daraxonrasib arm and 3.6 months (95% CI: 2.9, 4.2) in the SOC arm (Hazard ratio 0.49 [95% CI: 0.38, 0.64]; p-value <0.0001). ORR was 30% (95% CI: 25, 36) and 11% (95% CI: 7, 15) in the respective arms (p-value <0.0001).

The daraxonrasib prescribing information includes warnings and precautions for dermatologic and soft tissue toxicity, stomatitis and oral disorders, diarrhea, gastrointestinal perforation, interstitial lung disease (ILD)/pneumonitis, and embryo-fetal toxicity.

Recommended Dosage

The recommended daraxonrasib dose is 300 mg orally once daily until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada (HC). The European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) were official observers of this review. The applications may still be under review at the other regulatory agencies.

This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application approximately 6.5 months ahead of the FDA goal date.

This application is part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, which is designed to accelerate the review of products with the potential to address key national priorities. Daraxonrasib received breakthrough therapy designation and orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.