FDA Approves First-in-Class Rasonque for Metastatic Pancreatic Adenocarcinoma

The FDA approved daraxonrasib (Rasonque, Revolution Medicines), an oral RAS inhibitor taken once daily, for adults with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multiagent systemic therapy. The agency characterized Rasonque as the first-in-class targeted therapy approved for metastatic pancreatic cancer.

Daraxonrasib targets multiple forms of RAS, a protein the FDA identified as a key driver of tumor growth in most patients with pancreatic adenocarcinoma. The disease arises from cells lining the pancreatic ducts. Citing National Cancer Institute data, the FDA said pancreatic adenocarcinoma accounts for approximately 90% to 95% of the 67,000 new pancreatic cancer cases diagnosed annually in the US. Although it represents about 3.2% of all cancer diagnoses, the disease accounts for a disproportionately high share of cancer deaths, which the agency attributed to typically late detection, an aggressive disease course, and historically limited treatment options.

In a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, median overall survival was 13.2 months with Rasonque compared with 6.7 months with standard chemotherapy.

The most common side effects were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations and Priority Review. The application was also reviewed under the Commissioner’s National Priority Voucher pilot program, which is intended to accelerate reviews of therapies addressing national public health priorities. The agency said approval was granted 6.5 months before the user fee deadline. In May, the FDA had permitted the sponsor to initiate an expanded access treatment protocol for investigational daraxonrasib before approval under applicable FDA regulations.

Source: US Food and Drug Administration. FDA approves first in class targeted therapy for metastatic pancreatic cancer. Press release. US Food and Drug Administration; August 26, 2026. Accessed August 26, 2026.