Clinical Report: FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer

Overview

The FDA has approved daraxonrasib, a multi-selective RAS(ON) inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received prior systemic therapy. This approval is based on the RASolute 302 trial.

Background

Pancreatic cancer remains one of the most challenging malignancies to treat, with limited therapeutic options available for patients with metastatic disease. The approval of daraxonrasib provides a new treatment option for this patient population.

Data Highlights

Key Findings

• Daraxonrasib is the first approved RAS-targeted therapy for pancreatic cancer.
• The RASolute 302 trial showed daraxonrasib nearly doubled median overall survival compared to chemotherapy.
• Median overall survival was 13.2 months for daraxonrasib versus 6.7 months for chemotherapy.
• Median progression-free survival was 7.2 months for daraxonrasib compared to 3.6 months for chemotherapy.
• Objective response rates were 30% for daraxonrasib and 11% for chemotherapy.
• The FDA approval was granted 6.5 months ahead of the goal date.

Clinical Implications

Daraxonrasib is approved for adults with metastatic pancreatic adenocarcinoma who have received prior systemic therapy.

Conclusion

The FDA has approved daraxonrasib for the treatment of metastatic pancreatic cancer.

Related Resources & Content

1. FDA, FDA, 2026 -- FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma
2. Dana-Farber, Dana-Farber, 2026 -- FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer Following Landmark Clinical Trial Led by Dana-Farber
3. The ASCO Post, The ASCO Post, 2026 -- FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
4. ESMO, Annals of Oncology, 2026 -- ESMO Clinical Practice Guideline Express Update on daraxonrasib in the treatment of metastatic pancreatic cancer
5. the asco post — FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
6. The ASCO Post — Daraxonrasib Extends Median Survival in Previously Treated Pancreatic Cancer
7. FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma | FDA
8. ESMO Clinical Practice Guideline Express Update on daraxonrasib in the treatment of metastatic pancreatic cancer - Annals of Oncology