FDA Approves Rasonque, First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer

The U.S. Food and Drug Administration (FDA) has approved Rasonque (Daraxonrasib), a once-daily targeted therapy for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.

The Aug. 26 approval provides a new treatment option for people with metastatic pancreatic cancer, one of the most difficult cancers to treat. The approval comes after a phase 3 clinical trial showed that Rasonque significantly improved overall survival compared with chemotherapy.

What Is Rasonque?

Rasonque is an oral RAS inhibitor designed to target multiple forms of the RAS protein, which plays an important role in driving cancer growth.

RAS mutations are found in more than 90% of pancreatic ductal adenocarcinomas, the most common type of pancreatic cancer. Rasonque is designed to block active RAS signaling, potentially slowing the growth and spread of cancer cells.

The FDA describes Rasonque as a first-in-class targeted therapy for metastatic pancreatic cancer.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer,” Acting FDA Commissioner Kyle Diamantas, J.D., said in the FDA announcement.

Who Can Receive Rasonque for Pancreatic Cancer?

The FDA approved Rasonque for adults with metastatic pancreatic adenocarcinoma who:

• Have received at least one prior systemic therapy; or
• Are not candidates for multiagent systemic therapy.

Metastatic pancreatic cancer is cancer that has spread from the pancreas to other parts of the body.

Approximately 90% to 95% of pancreatic cancer cases in the United States are pancreatic adenocarcinoma, according to the FDA. The disease accounts for a disproportionately high number of cancer deaths because it is often diagnosed at an advanced stage and can be difficult to treat.

How Effective Is Rasonque for Metastatic Pancreatic Cancer?

The FDA's approval was supported by a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma.

In the overall study population, patients who received Rasonque had a median overall survival of 13.2 months, compared with 6.7 months for those who received chemotherapy. The treatment reduced the risk of death by approximately 60%.

The study also found that Rasonque delayed cancer progression. Median progression-free survival was 7.2 months with Rasonque compared with 3.6 months with chemotherapy.

Among the patients with RAS G12 mutations, which represented 91.8% of participants, median overall survival was 13.2 months with Rasonque compared with 6.6 months with chemotherapy.

What Are the Side Effects of Rasonque?

As with any cancer treatment, Rasonque can cause side effects.

The most common side effects reported with Rasonque include:

• Rash
• Diarrhea
• Stomatitis, or inflammation of the mouth
• Nausea
• Fatigue
• Vomiting
• Abdominal pain
• Edema, or swelling caused by fluid buildup
• Decreased appetite
• Hemorrhage, or bleeding

In the phase 3 trial, 61.8% of patients receiving Rasonque experienced grade 3 or higher adverse events, compared with 69.6% of patients receiving chemotherapy. Treatment-related side effects led to discontinuation in 1.2% of patients receiving Rasonque and 11.2% of those receiving chemotherapy.

Patients should discuss potential side effects with their health care team before starting treatment and report new or worsening symptoms during therapy.

Why Is This Approval Important for Pancreatic Cancer?

Pancreatic cancer has historically had limited treatment options, particularly after the disease progresses following initial therapy.

The results from the RASolute 302 trial showed that targeting the RAS pathway could provide a substantial survival benefit for people with previously treated metastatic pancreatic cancer. The findings were published in the New England Journal of Medicine and presented at the 2026 American Society of Clinical Oncology Annual Meeting.

The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations and Priority Review for the application. The application was also reviewed through the Commissioner's National Priority Voucher pilot program, which is intended to accelerate review of treatments addressing national public health priorities.

What Does This Mean for Patients With Metastatic Pancreatic Cancer?

The approval gives patients and their doctors another treatment option after previous therapy or for patients who are not candidates for multiagent chemotherapy.

For patients with metastatic pancreatic adenocarcinoma, treatment decisions can depend on factors including previous therapies, overall health, tumor characteristics and the patient's goals and preferences. Patients should talk with their oncology team about whether Rasonque is appropriate for their individual situation.

The approval also represents progress in developing targeted treatments for pancreatic cancer by directly addressing the RAS pathway, one of the key drivers of the disease.

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