The FDA has granted permission for Revolution Medicines to provide access to its investigational RAS inhibitor, daraxonrasib, through an Expanded Access Program (EAP) for certain patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Previously, daraxonrasib was available only through participation in one of the company’s clinical trials. The new expanded access pathway may allow some patients with previously treated metastatic PDAC to receive the drug outside of a trial setting when other treatment options are limited.
Daraxonrasib has generated significant interest following encouraging results from the phase III RASolute 302 clinical trial. In that study, patients with previously treated metastatic pancreatic cancer (PDAC) who received daraxonrasib lived a median of 13.2 months, compared with 6.7 months for patients receiving chemotherapy. Researchers also reported that side effects were generally manageable and consistent with expectations for this type of therapy. Based on these promising findings, Revolution Medicines requested permission to initiate an Expanded Access Protocol (EAP) for their experimental RAS(ON) inhibitor.
An EAP allows physicians in the US to request use of investigational drugs for patients not enrolled in the drug’s clinical trials. Sometimes called “compassionate use,” this pathway may allow patients with serious illnesses to receive investigational treatments before full FDA approval. Like a clinical trial, expanded access programs have strict criteria and require physician oversight.
For daraxonrasib, the EAP is intended for adult patients with previously treated metastatic pancreatic cancer who:
- Are no longer benefiting from standard treatment options
- Are unable to enroll in an active clinical trial
- Meet specific medical eligibility requirements established by the program
The first step to accessing daraxonrasib through the EAP is to speak with your oncology team.
Patients cannot apply for daraxonrasib on their own. Requests must be submitted directly by a treating physician to Revolution Medicines. If a physician believes a patient may qualify, the company will review the request and determine eligibility based on medical criteria, regulatory requirements, and drug availability. Access is evaluated on a case-by-case basis.
Because demand for this therapy is high, not every request may be approved. However, the expanded access program represents an important opportunity for some patients who previously had limited options outside of clinical trials.
Patients with metastatic PDAC have few treatment options. Standard first-line therapies typically include chemotherapy, generally FOLFIRONX or the combination of gemcitabine and Nab-paclitaxel and have no other treatment options if these options stop working.
The emergence of targeted therapies like daraxonrasib reflects meaningful progress in pancreatic cancer research and may offer some patients another treatment pathway that could extend survival and improve quality of life.
Importantly, daraxonrasib is only one part of a broader wave of KRAS-focused research currently underway. Additional clinical trials are already exploring the drug in earlier treatment settings, including as a first-line therapy and in patients who have undergone surgery.
While no single treatment works for everyone, advances like these are helping move pancreatic cancer care toward a more personalized future.
If you are interested in learning more about daraxonrasib or other clinical trial options, consider asking your care team:
- Have I had comprehensive biomarker or genetic testing?
- Could I qualify for a KRAS-targeted therapy or clinical trial?
- Am I eligible for the daraxonrasib Expanded Access Program?
- Are there ongoing clinical trials that may be appropriate for me now or in the future?
Progress in pancreatic cancer research continues to accelerate, and new treatment approaches are offering hope where few options once existed.
A pancreatic cancer diagnosis can feel overwhelming, especially when navigating treatment decisions, clinical trials, and emerging therapies. Staying informed and connected to experienced care teams can help patients and families navigate these decisions with greater confidence. The Hirshberg Foundation for Pancreatic Cancer Research is here to help patients and families access trusted information, educational resources, and supportive programs throughout every stage of the journey.
