Update: FDA grants expanded access to an investigational drug for pancreatic cancer

RELEVANCE

Most relevant for: People with previously treated advanced pancreatic cancer.

It may also be relevant for:

• people with metastatic or advanced cancer
• people with pancreatic cancer

Relevance: Medium

Research Timeline: Human Research

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What is this update about?

Through a process called expanded access, the FDA is allowing more people with pancreatic cancer to receive treatment with an experimental drug called daraxonrasib. The FDA decision was based on early, promising results from a clinical trial of this drug in which some participants’ tumors shrank or stopped growing after treatment with daraxonrasib (see Tab 2 for more).

The FDA’s expanded access pathway may be an option for receiving investigational drugs outside clinical trials when other treatment options are limited for people with serious or life-threatening illnesses (see Tab 3 for more).

Why is this update important?

Pancreatic cancer is an aggressive, difficult-to-treat type of cancer that is often diagnosed when it is already at an advanced stage. People whose cancer doesn’t respond to treatment or comes back after treatment have limited options. By expanding access to daraxonrasib, more people will be able to receive this promising experimental treatment without joining a clinical trial.

What is daraxonrasib?

Up to 90% of pancreatic cancers have RAS mutations. Daraxonrasib is a targeted therapy designed specifically for cancers with RAS mutations.

Daraxonrasib works by blocking RAS, a protein that helps pancreatic cancers grow. Daraxonrasib is still being studied and is not yet approved by the FDA.

Who may be able to access this drug?

According to the FDA announcement, expanded access to daraxonrasib is for:

• People with metastatic pancreatic ductal adenocarcinoma (mPDAC).
• People whose cancer has already been treated and continues to progress.
• People who have limited or no remaining standard treatment options.

Eligibility for expanded access is determined by the treating oncologist and the drug manufacturer. Revolution Medicines cannot accept requests directly from patients or caregivers.

To initiate an EAP request or inquiry, physicians may contact [email protected].

How can patients gain access?

Patients cannot apply directly for expanded access. Instead:

• Patients must work with their oncologist to determine if expanded access may be appropriate.
• Oncologists must submit a request to Revolution Medicines, the drug’s manufacturer.
• If the patient meets the eligibility criteria and the sponsor agrees, the FDA will review the request.
• If approved, the patient may receive the drug under the expanded access process.

Not all requests are approved, and availability may be limited.

What does this mean for me?

If you have been diagnosed with pancreatic cancer that has returned or worsened after treatment, and you have few remaining treatment options, this expanded access decision may offer an opportunity for additional treatment.

Expanded access is not the same as an FDA approval, so speak with your doctor about the benefits and risks of the drug. If you decide to pursue treatment with daraxonrasib, your doctor will need to contact the drug manufacturer to determine if you are eligible and can receive the drug.

Clinical trial results lead to expanded access

The FDA’s expanded access decision was based on early clinical trial results published in early May 2026. In this study, 168 people with metastatic pancreatic cancer whose tumors had RAS mutations but failed to respond to treatment were treated with daraxonrasib.

Among people with any RAS mutation who were previously treated for pancreatic cancer, results from the study suggest that daraxonrasib may help shrink cancers and slow cancer growth.

• When daraxonrasib was used as a second-line treatment after chemotherapy, the time until cancer worsened or progressed was about 8 months, and overall survival was almost 16 months.
• When daraxonrasib was used as a third-line treatment after chemotherapy, the time until cancer worsened or progressed was about just over 4 months, and overall survival was 9 months.

Results of a second study will be presented at the American Society of Clinical Oncology 2026 annual meeting. This study compared daraxonrasib versus chemotherapy for second-line treatment of stage 4 disease.

The results of these two studies support the ongoing RASolute 302 study, a global randomized phase 3 trial of daraxonrasib versus chemotherapy as second-line treatment in patients with mPDAC (ClinicalTrials.gov number, NCT06625320).

Most participants experienced side effects. About 30% had serious (grade 3) side effects. The most common were:

• rash
• diarrhea
• nausea
• mouth sores
• vomiting
• fatigue

In addition, there are a number of interactions between daraxonrasib and other medications. A careful review of an individual’s medication list should be performed prior to starting daraxonrasib.

This is an early study, but the results suggest that daraxonrasib could become a new option for some patients. Talk with your doctor about tumor testing, clinical trials or whether expanded access may be appropriate for you.

References

U.S. Food and Drug Administration (2026, May 1). FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug [Press release].

Authors: BM. Wolpin, W Park, I Garrido-Laguna, et al. Daraxonrasib in Previously Treated Advanced RAS-Mutated Pancreatic Cancer. N Engl J Med 2026; 394:1790-1802

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to ensure scientific integrity.

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posted 5/29/26

What is the expanded access process?

The FDA’s expanded access allows patients with serious or life‑threatening illnesses to try an investigational drug when no comparable or satisfactory treatment options are available and when participation in a clinical trial is not possible.

Under expanded access:

• The drug is still considered experimental.
• The FDA reviews requests to help ensure patient safety.
• Access must be requested by a treating physician, rather than the patient.

Expanded access does not guarantee benefit, and risks may remain unknown because the drug is still being studied.

• Is my pancreatic cancer positive for a RAS mutation?
• Is daraxonrasib a possible treatment option for me?
• Can you apply for expanded access for daraxonrasib on my behalf?
• What side effects should I expect from treatment, and how can I manage them?
• How long might this treatment keep my cancer under control?
• Do I qualify for any treatment clinical trials?