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Daraxonrasib FDA Approval for Pancreas | TrialFinder
HomeResourcesDaraxonrasib (RASONQUE) Is Now FDA-Approved for Metastatic Pancreatic Cancer

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Published · July 10, 2026· Updated September 28, 2026

Daraxonrasib (RASONQUE) Is Now FDA-Approved for Metastatic Pancreatic Cancer

On this page
  1. 1.What the FDA approval covers
  2. 2.Why this matters
  3. 3.What this does not mean
  4. 4.Studies that are still going
  5. 5.What to ask the oncologist
  6. 6.Sources

Daraxonrasib (brand name RASONQUE) is FDA-approved. It is no longer only a trial drug. Ask the treating oncologist whether this approval fits this case.

On August 26, 2026 the FDA approved daraxonrasib (RASONQUE, Revolution Medicines), a RAS GTPase family inhibitor. The labeled use is adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy.

This page was first published in July 2026, when the drug was still investigational and some people could try to reach it through expanded access. That is no longer the current path in the United States. The practical next step is to ask whether the approved use matches the diagnosis and the treatments already given.

What the FDA approval covers

In plain language, the FDA decision applies when all of this is true:

  • The cancer is metastatic pancreatic adenocarcinoma (the common form of pancreatic cancer that has already spread).
  • The person is an adult.
  • There has been at least one prior systemic therapy, or combination (multiagent) systemic therapy is not a realistic option.

"Systemic therapy" usually means treatment that travels through the body, such as chemotherapy. "Multiagent" means more than one drug given together. The oncologist is the one who can say whether this description matches the pathology report, the stage, and the treatments already used.

The approval is a US FDA decision. What is available, covered, or imported elsewhere is a separate question.

Why this matters

Pancreatic cancer has very few targeted options. RAS mutations drive the vast majority of cases. Daraxonrasib is a RAS GTPase family inhibitor, so it is a different class of option than standard chemotherapy. That is why the approval is worth raising, even though it does not fit every person.

Efficacy was evaluated in the randomized RASolute 302 trial. Group results from a trial are not a prediction for one person.

What this does not mean

The approval applies to the stated population. It is not a cure.

It does not automatically apply to earlier-stage disease, to every pancreatic tumor type, or to care outside the United States. A longer median survival in a trial is a group result. It is not a promise of how long any one person will live, and it does not mean the cancer is gone.

Studies that are still going

One approved use does not close the research. Ongoing studies continue to test daraxonrasib in earlier lines of treatment and in combinations.

To see recruiting pancreatic cancer studies, use the full TrialFinder pancreatic cancer search. The pancreatic cancer clinical trials guide explains how stage and biomarkers change which listings may fit. A trial is one option to discuss. It is not automatically better than an approved treatment.

What to ask the oncologist

A short list is usually enough:

  1. Does this FDA indication match this diagnosis and treatment history?
  2. Has combination (multiagent) systemic therapy already been used, or is it not a realistic option?
  3. What is actually available where care is given?
  4. Has the tumor had molecular testing, and does that change the discussion?
  5. Are there recruiting trials in an earlier line or a combination that should be compared with the approved use?

If it helps to plan the appointment, How to Talk to Your Doctor About Clinical Trials walks through how to raise the topic and what to bring.

Sources

  • FDA: FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma (August 26, 2026).
  • ClinicalTrials.gov: RASolute 302 (NCT06625320).

FAQ

Is daraxonrasib still only available in clinical trials?

No. On August 26, 2026 the FDA approved daraxonrasib (brand name RASONQUE, Revolution Medicines) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy. Ask the treating oncologist whether that description matches this case.

Who is the FDA approval for?

The labeled use is adults with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy, or adults who are not candidates for multiagent systemic therapy. It does not automatically cover earlier-stage disease or every pancreatic tumor type. Availability outside the United States depends on local regulators and coverage.

Why does a RAS-family inhibitor matter in pancreatic cancer?

Pancreatic cancer has very few targeted options. RAS mutations drive the vast majority of cases. Daraxonrasib is a RAS GTPase family inhibitor, a different class of option than standard chemotherapy. That does not mean it fits every person, or that it replaces a conversation with the oncologist.

Is this a cure?

No. Approval applies to the stated population. It is not a cure, and trial results are group results, not a promise for one person.

Are there still clinical trials of daraxonrasib?

Yes. Ongoing studies continue to test daraxonrasib in earlier lines of treatment and in combinations. The approved use and a trial listing are different questions. Search TrialFinder for recruiting pancreatic cancer trials and take specific listings to the oncologist.

Related conditions

Pancreatic Cancer Clinical Trials: Resectable or Metastatic, and Why KRAS Matters Resectable or metastatic, KRAS, BRCA or MSI: how each detail changes which pancreatic cancer trials may fit. Recruiting studies included.

Further reading

How to Talk to Your Doctor About Clinical Trials What questions should you ask your doctor about clinical trials? A step-by-step guide for patients: when to bring it up, what to prepare, and what to do after.

Key Clinical Trial Terms Plain-language explanations of terms patients and families encounter during the clinical trial process.

Before You Join a Clinical Trial: Screening, Informed Consent, and Red Flags Learn what screening and informed consent involve before you join a clinical trial, which questions to ask, and which red flags mean you should walk away.

Osimertinib for Uncommon EGFR Mutations: What the Evidence Shows Osimertinib (Tagrisso) for uncommon EGFR mutations such as G719X, S768I, L861Q, and exon 20 insertions: what the evidence covers, plus active clinical trials.

Clinical Trials in Mental Health: What Patients and Families Should Know Mental health clinical trials may test medication, therapy, or devices. How they differ from cancer trials, and how to start looking.

The Reminder Moderna and Merck's Personalized mRNA Cancer Vaccine Gives Us About Clinical Trials Moderna and Merck's personalized mRNA vaccine met Phase 3 goals in melanoma. What that shows about joining a clinical trial.

Start Here: How to Search for Clinical Trials on TrialFinder A step-by-step guide to finding clinical trials on TrialFinder. Learn how to search by condition, use filters, and understand your results.

What is a Clinical Trial? (It's More Than You Think) How clinical trials work, why they matter, and what patients should know before considering one.

Not a Perfect Match? Tips for Getting Into a Clinical Trial Anyway A rejection from a clinical trial doesn't have to be the end. Practical tips for patients and caregivers who hit a wall.

How to Talk About Clinical Trials with a Family Member A guide for caregivers on introducing clinical trials to a loved one who is hesitant, tired, or afraid.

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This article was written by a patient advocate based on personal experience, not by a medical professional. It is not medical advice. Consult your doctor before making any medical decisions.

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