Clinical Report: FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer

Overview

Daraxonrasib has been approved by the FDA as the first RAS-targeted therapy for metastatic pancreatic adenocarcinoma. This approval is based on the pivotal RASolute 302 trial results, which showed median overall survival of 13.2 months for daraxonrasib compared to 6.7 months for chemotherapy.

Background

Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest cancers, with a five-year relative survival rate of approximately 3%. Current treatment options are limited, particularly for patients with metastatic disease. The approval of daraxonrasib provides a new treatment option for this cancer type.

Data Highlights

Key Findings

• Median overall survival was 13.2 months for daraxonrasib versus 6.7 months for chemotherapy.
• Patients receiving daraxonrasib had a median progression-free survival of 7.2 months compared to 3.6 months with chemotherapy.
• The objective response rate was significantly higher with daraxonrasib (31.6%) than with chemotherapy (11.2%).
• Among patients with a known RAS G12 mutation, 33.2% experienced substantial tumor shrinkage with daraxonrasib.

Clinical Implications

The approval of daraxonrasib allows for treatment of adults with metastatic pancreatic adenocarcinoma who have received prior systemic therapy or are not candidates for multiagent systemic therapy.

Conclusion

The FDA's approval of daraxonrasib provides a new treatment option for patients with metastatic pancreatic cancer.

Related Resources & Content

1. FDA, FDA, 2026 -- FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma
2. The ASCO Post, The ASCO Post, 2026 -- FDA Approves Daraxonrasib for Metastatic Pancreatic Adenocarcinoma
3. The ASCO Post, The ASCO Post, 2026 -- Daraxonrasib Nearly Doubles Survival in Previously Treated Metastatic Pancreatic Cancer
4. The ASCO Post, The ASCO Post, 2026 -- FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
5. The ASCO Post — Daraxonrasib Extends Median Survival in Previously Treated Pancreatic Cancer
6. FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma | FDA
7. NCCN Guidelines Version 2.2025
8. Pipeline – Revolution Medicines