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The FDA has approved a new pancreatic cancer treatment for adults with metastatic pancreatic adenocarcinoma. The agency announced the approval of Rasonque (daraxonrasib) on Aug. 26, 2026.
The once-daily tablet targets RAS proteins, which play a key role in tumor growth. The approval gives some patients with advanced pancreatic cancer another treatment option.
FDA Approves Rasonque for Pancreatic Cancer
The FDA approved Rasonque for adults with metastatic pancreatic adenocarcinoma. Patients must have received at least one previous systemic treatment.
The drug can also help adults who are not candidates for multiagent systemic therapy.
The FDA described the approval as an important new option for people facing an aggressive form of cancer. The agency also highlighted the speed of its review.
Rasonque received approval 6.5 months before the user fee deadline, according to the FDA.
Clinical Trial Shows Longer Survival
Researchers evaluated Rasonque in a randomized, open-label, multicenter clinical trial involving 500 adults.
All participants had previously treated metastatic pancreatic adenocarcinoma.
Patients who received Rasonque had a median overall survival of 13.2 months. Those who received standard chemotherapy had a median overall survival of 6.7 months.
The results supported the FDA’s decision to approve the targeted therapy.
Pancreatic Cancer Remains Difficult to Treat
Pancreatic adenocarcinoma accounts for most pancreatic cancer cases in the United States.
The National Cancer Institute estimates that about 90% to 95% of the roughly 67,000 pancreatic cancer cases diagnosed annually involve pancreatic adenocarcinoma.
Pancreatic cancer can remain difficult to treat because doctors often detect it at an advanced stage. The disease can also progress aggressively.
The need for additional treatment options remains high for patients with metastatic disease.
Rasonque Targets RAS Proteins
Rasonque works by targeting multiple forms of RAS, a protein involved in tumor growth.
The FDA granted the drug Breakthrough Therapy and Orphan Drug designations. The agency also gave Rasonque Priority Review for the pancreatic cancer indication.
The application received additional review through the Commissioner’s National Priority Voucher pilot program. The program aims to speed reviews of therapies that address important public health priorities.
FDA Lists Potential Side Effects
Like other cancer treatments, Rasonque can cause side effects.
The FDA lists rash, diarrhea, mouth inflammation, nausea and fatigue among the most common reactions. Other reported side effects include vomiting, abdominal pain, swelling, decreased appetite and bleeding.
Patients should discuss potential risks and benefits with their health care providers before starting treatment.
Revolution Medicines Receives Approval
The FDA granted the approval to Revolution Medicines, Inc.
The agency previously issued a “safe to proceed” letter in May. That action allowed the company to begin an expanded access treatment protocol for Rasonque before its approval.
The new approval now provides an additional treatment option for eligible adults with metastatic pancreatic adenocarcinoma.
For patients and families facing advanced pancreatic cancer, the development represents another step toward expanding treatment choices for a disease that has historically presented significant challenges.
Source: U.S. Food and Drug Administration (FDA), Aug. 26, 2026.
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