Daraxonrasib FDA Expanded Access Rollout Meets Heavy Clinical Demand and Operational Hurdles

Daraxonrasib FDA Expanded Access Rollout Meets Heavy Clinical Demand and Operational Hurdles

Following the unprecedented clinical trial results presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the U.S. Food and Drug Administration (FDA) has authorized an Expanded Access Program (EAP) for Revolution Medicines' oral RAS(ON) inhibitor daraxonrasib (RMC-6236). The program allows eligible patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) to access the investigational therapy while its New Drug Application (NDA) undergoes regulatory review.

However, on-the-ground clinicians report that translating this regulatory permission into active patient treatment is meeting severe logistical, financial, and operational bottlenecks.¹

Unprecedented Clinical Demand

Public awareness of daraxonrasib has exploded following the publication of trial data in The New England Journal of Medicine and mainstream press coverage. Oncologists report an extraordinary surge in patient inquiries. Dr. Daniel A. King, a gastrointestinal medical oncologist at Northwell Health's R.J. Zuckerberg Cancer Center, highlighted the scale of the demand:

"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 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."

This enthusiasm is backed by Phase 3 RASolute 302 (NCT06625320) trial data comparing daraxonrasib monotherapy to standard chemotherapy in previously treated metastatic PDAC. The trial met its primary and secondary endpoints, demonstrating statistically significant improvements in overall survival (OS) and progression-free survival (PFS), which many experts view as the most meaningful advance in pancreatic oncology in decades.²

Operational and Logistical Bottlenecks

Despite the FDA's authorization, accessing daraxonrasib through the EAP remains a slow, multi-step process that can take over a month. Key barriers include:

• Institutional Review Board (IRB) Approval: Because daraxonrasib is not yet FDA-approved, health systems must open up an expanded access protocol that mirrors a clinical trial, requiring formal ethical review by institutional boards.
• Financial Burden: Since the drug is investigational, it is not covered by insurance. Health systems must individually review and absorb the costs of care and administration.
• Individual Provider Applications: Oncologists must submit lengthy, patient-specific applications to the manufacturer and contract research organizations to prove patient eligibility based on strict inclusion and exclusion criteria.
• Supply Chain Delays: Even after an application is approved, shipping and receiving the drug takes weeks.

Dr. King described the frustrating gap between clinical promise and practical access:

"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... 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."

Looking Ahead

The clinical oncology community expects the FDA to grant full approval for daraxonrasib by late 2026, which will eliminate the logistical hurdles of the EAP by allowing standard insurance coverage and commercial distribution. Meanwhile, clinical trials are already exploring moving daraxonrasib into first-line combination regimens to further improve outcomes for metastatic pancreatic cancer.