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

More rating details

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 is a pill taken once a day. 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 two clinical trial results published in May 2026.

The first study was an early-stage clinical trial of 168 people with metastatic pancreatic cancer which no longer responded to prior treatment. All participants had cancers with a biomarker known as a RAS gene mutation.

Results suggest that daraxonrasib may help shrink cancer 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.

The second study presented at the 2026 American Society of Clinical Oncology (ASCO) annual meeting compared daraxonrasib versus chemotherapy for second-line treatment of metastatic pancreatic cancer. The 500 participants with previously treated mPDAC were randomized and treated with daraxonrasib or chemotherapy.

Results from this phase 3 clinical trial showed that overall survival and time until cancer returned were better in patients who received daraxonrasib compared to chemotherapy.

• Overall survival was 13.2 months among participants who received daraxonrasib compared to 6.7 months among participants who received chemotherapy.
• Time until cancer came back was 7.2 months among participants who received daraxonrasib compared to 3.6 months among participants who received chemotherapy.

The results of these two studies support the ongoing and new studies looking at daraxonrasib for the treatment of advanced pancreatic cancer. You can see a list of these studies here.

Most participants experienced side effects. About 30% of participants 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. Individuals should talk with their healthcare team about all prescription medications and other supplements they take prior to starting daraxonrasib.

This is an early study, but the results suggest that daraxonrasib could become the new standard for people with mPDAC. 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].

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

EM O’Reilly, ZA. Wainberg, AE. Hendifar, et al. Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer. N Engl J Med; Published May 31, 2026. DOI: 10.1056/NEJMoa2605555

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.

Share your thoughts on this XRAY review by taking our brief survey. 

updated 6/3/26

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.

Who covered this study?