FDA Approves Daraxonrasib for Metastatic Pancreatic Adenocarcinoma

Clinical Summary:

• Based on results from a randomized, open-label, multicenter trial, the FDA has approved daraxonrasib for adults with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multiagent systemic therapy. 
• In this study of 500 patients, daraxonrasib improved median overall survival to 13.2 months compared with 6.7 months with standard chemotherapy, with common adverse reactions including rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. 
• This approval provides a new RAS-targeted treatment option for patients with advanced pancreatic adenocarcinoma, a disease with historically limited therapeutic options.

On August 26, 2026, the US Food and Drug Administration (FDA) approved daraxonrasib (Rasonque, Revolution Medicines, Inc) for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multiagent systemic therapy.

Daraxonrasib is an oral, once-daily RAS inhibitor designed to target multiple forms of RAS, a protein that drives tumor growth in most patients with pancreatic adenocarcinoma.

The efficacy of daraxonrasib was evaluated in RASolute 302, a randomized, open-label, multicenter trial enrolling 500 patients with metastatic pancreatic adenocarcinoma who experienced disease progression after 1 prior line of systemic therapy. Patients were randomized 1:1 to receive either daraxonrasib or physician’s choice of standard-of-care (SOC) chemotherapy.

The major efficacy end points 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. Objective response rate (ORR) was an additional efficacy end point. 

In the overall population, the median OS was 13.2 months (95% confidence interval [CI], 10 to not estimable [NE]) with daraxonrasib compared with 6.7 months (95% CI, 5.8 to 8) with chemotherapy (hazard ratio [HR], 0.4; 95% CI, 0.3 to 0.53; P < .0001). Median PFS was 7.2 months (95% CI, 5.7 to 7.5) in the daraxonrasib arm and 3.6 months (95% CI, 2.9 to 4.2) in the chemotherapy arm (HR, 0.49; 95% CI, 0.38 to 0.64; P < .0001). The ORR was 30% (95% CI, 25 to 36) and 11% (95% CI, 7 to 15), respectively (P < .0001). 

The most common adverse reactions associated with daraxonrasib included rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. 

The 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.

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

Daraxonrasib received Breakthrough Therapy and Orphan Drug designations and was granted Priority Review for this indication. The application was also reviewed under the FDA Commissioner’s National Priority Voucher pilot program.

In May, the FDA issued a “safe to proceed” letter allowing the sponsor to initiate an expanded access treatment protocol for daraxonrasib, enabling eligible patients to access the investigational therapy prior to approval.

“This drug showed unprecedented results in an area of high unmet need,” stated Angelo de Claro, MD, director of the FDA’s Oncology Center of Excellence. “The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions.”

Source:

US Food and Drug Administration. FDA approves first in class targeted therapy for metastatic pancreatic cancer. Accessed on August 26, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-class-targeted-therapy-metastatic-pancreatic-cancer

US Food and Drug Administration. FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma. Accessed on August 26, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma