Daraxonrasib Demand Grows Amid Expanded Access Rollout in Metastatic PDAC

The FDA's recent authorization of an expanded access program (EAP) for daraxonrasib (RMC-6236) has sparked widespread interest across the pancreatic cancer community, creating both hope and urgency among patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and the physicians who treat them. The investigational RAS(ON) inhibitor, which holds breakthrough therapy and orphan drug designations from the FDA, is now available through an EAP for eligible patients with previously treated metastatic PDAC while regulatory review continues.

Enthusiasm surrounding daraxonrasib has been fueled by promising clinical data and anticipation of the results from the phase 3 RASolute 302 trial (NCT06625320), which were presented during a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The study evaluated daraxonrasib monotherapy against chemotherapy in previously treated metastatic PDAC and met its primary and key secondary end points, with top-line data demonstrating significant improvements in overall survival and progression-free survival. For many oncologists, the findings represent one of the most meaningful advances in pancreatic cancer treatment in years.

Yet as excitement builds, so does the pressure on oncologists fielding a growing number of questions from patients eager to access the drug. At the same time, oncologists must navigate lengthy application processes, institutional review requirements, financial considerations, and logistical barriers associated with delivering an investigational therapy outside of a clinical trial.

“Pressure is an interesting word, and I would say it's not too far off from how it feels,” Daniel A. King, MD, PhD, told Targeted Oncology. “Our job as doctors is to find the best therapies that are available for patients, and many of us face a situation where patients have extinguished standard lines of therapy, and we are looking for alternative therapeutic options…so yes, I think there is certainly motivation on both the provider and the patient to help patients gain access to the drug.”

In an interview with Targeted Oncology, King, a gastrointestinal medical oncologist at the RJ Zuckerberg Cancer Center of Northwell Health Cancer Institute, discussed the intense public interest surrounding daraxonrasib, the practical challenges of implementing the EAP, and why the emerging clinical trial data may ultimately reshape the treatment landscape for metastatic PDAC.

Targeted Oncology: What is the situation on the ground right now regarding accessing daraxonrasib, and how are you counseling patients in your practice on participating in the EAP?

Daniel A. King, MD, PhD: As a medical oncologist who treats pancreatic cancer primarily, it is a big topic in my clinic. I would say easily half of patients are asking about this drug, so the awareness in the public is really extraordinary. I think many of them have either heard of the New England Journal of Medicine article¹ or just have seen in press—because it was actually in the New York Times—that there's this drug coming, daraxonrasib. I think for many patients, they don't quite know what it is; they just know that there's something that they feel is maybe miraculous, and they are asking me to get them access to it. Where I feel we are now is in very much of [a] transition, or the interface between where we as a field are recognizing that these drugs are highly effective, yet access to them is still extremely limited. Access to daraxonrasib specifically, or the new class of drug, the RAS inhibitors, right now is primarily still only in clinical trials. The [EAP] by Revolution Medicines and the contract research organization that's helping distribute the drug is coming online, but no drug has yet been released by that mechanism, so we're not yet at a position where we can get access to daraxonrasib today.

I think that frustrates a lot of us—not only patients but [also] providers. It frustrates patients, many of whom are looking for a new treatment option and are hopeful by the advance that this drug purports for the field. On the other hand, not being able to get it immediately is a source of frustration for patients, because they feel like it's just out of reach. I think for providers, we feel somewhat similarly. Our job is to do everything possible to preserve life, and we do so with effective treatments, and now we know that there's a treatment that's on the horizon, yet the process to get the drug is unfortunately lengthy. Even now, we are telling patients that despite our most assertive requests to get the drug, it is a process in which we have to request the drug. It's an application, and that application takes time, and there are many aspects…in the chain of that application. In other words, there's many different steps that we have to go through, and even after the application is accepted, we're being told it will take at least a couple of weeks for the drug to be shipped, received, and made available for use. So even now, in the middle of May, we're telling patients that it could easily be 4 to 6 weeks before a drug is available.

What are the biggest operational hurdles oncologists face when trying to help patients access investigational drugs like daraxonrasib through expanded access?

This is not a drug that's FDA approved, and it's not a drug that's covered by insurance, so the standard route that we oncologists use to supply therapies to patients is very dissimilar.… Here, what we need to do is essentially open up what looks more like a clinical trial; it's not a trial per se, it's an expanded access protocol, but it is a document that needs to go through our institutional review board, so that is a hurdle that takes time for it to be reviewed. Our own institution needs to deem that it is ethical to pursue the drug in this manner. The resources that are needed for this are nontrivial, so again, if this were a standard drug covered through insurance, then this would simply be the insurance company paying for all aspects of care. And we're not in that situation here, so the institution ends up needing to cover costs for patients to access the drug. Our health care system here at Northwell Health, and many other health care systems, have made the decision to pursue that…financial sacrifice to benefit patients. Nevertheless, it is something that needs to go through a financial committee here and probably elsewhere to make sure that each case is being individually reviewed and is appropriate. That process takes some time. The providers need to apply for the drug, and that's not as simple as placing an order. We have an application process that we are being asked to fill out individually for each patient. We need to deem that the patient is eligible. That application process requires some patient information. It also has inclusion and exclusion criteria, so the providers are being asked to supply patient criteria, [and] that application process takes some time.

These are just some examples of the multiple different pieces of infrastructure that need to be considered at an institutional level for patients to gain access to the drug. I would say that for our patients [who] we are already seeing in clinic, I think providers feel a sense of responsibility in order to help patients get access to the drug. But I will also say that because not all institutions have this mechanism, there's also basically an induced demand on our providers to provide this drug for patients that are coming from other health care systems…perhaps community practices that may not have the infrastructure set up in order to gain access. So that's another important part of the consideration for access to this drug.

Do you view the data available so far as potentially practice-changing for metastatic PDAC? Are there still key questions you need answered?

Many of us are looking forward to the ASCO plenary talk on the RASolute 302 clinical trial. This is a phase 3 clinical trial that compared daraxonrasib monotherapy with chemotherapy, and the results are looking quite promising. I would not use the word miraculous; I [view it as a] substantial advance. In relative terms, the treatments look like they are 2 or 3 times better than the prior standard of care. In terms of the likelihood for the disease to shrink, we're also seeing quite nice advances in how long patients are on the drug without progression, and even some signals in how long they survive when given the drug, so those are all very encouraging.

In absolute terms, we are still struggling with treatments that are not cures. We are far from that, so we have a long way to go to fight for a cure for pancreatic cancer. But the standard of care…has the potential to shift because the encouraging data we're seeing are substantially better than the current standard of care. In my view, it is practice-changing, and I think that this therapy will change the standard of care. We will need to be mindful that the drug itself has some toxicities. Oncologists are not necessarily very comfortable managing some of those toxicities; they're different from the standard toxicities that we see from chemotherapy. It may require us to work more closely with some other colleagues in other departments such as dermatology, because of rash being a notable [adverse] effect. But nevertheless, the effectiveness of the drug looks very strong overall.

There are still some data that we need to know a little bit better. As I mentioned earlier, the drug is a RAS inhibitor. Not all patients with pancreatic cancer have a DNA mutation in the RAS gene family, and what we don't know quite yet is: How will the results translate to the so-called KRAS wild-type population? That's something I think requires more evidence, and I'm curious to see what comes out from the presentation and additional publications.

Nevertheless, I think the trial has great potential to be practice-changing when the FDA approval comes through, perhaps toward the end of the year. It will be a wonderful thing to augment access to patients so that we can overcome many of the logistical barriers that we described earlier, and then we're going to think about the next trial.

Daraxonrasib is not the end of the story. It's an important milestone in the management of metastatic pancreatic cancer, and no doubt there will be competitors that try to displace daraxonrasib. There will be similar strategies that use daraxonrasib but attempt to augment its response through combination with other drugs, and there will be the migration, very likely, of these RAS inhibitors into the frontline setting. As many phase 3 clinical trials are already underway, the landscape is going to be changing relatively quickly. I think it is really remarkable to see how the landscape in the field of pancreatic cancer is moving, and, thankfully, to great benefit to our patients who now have access to therapies that are substantially better than we've had for the past several decades.

REFERENCE

1. Wolpin BM, Park W, Garrido-Laguna I, et al; RMC-6236-001 Investigators. Daraxonrasib in previously treated advanced RAS-mutated pancreatic cancer. N Engl J Med. 2026;394(18):1790-1802. doi:10.1056/NEJMoa2505783