.png)
We are writing to share important news about a promising new treatment option for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Our practice has received approval through the FDA's Expanded Access Program (EAP) for daraxonrasib — and we are actively working to make this therapy available to eligible patients.
What the FDA Has Announced
On May 1, 2026, the U.S. Food and Drug Administration issued a "safe to proceed" letter to Revolution Medicines, authorizing an Expanded Access Treatment Protocol (EAP) for daraxonrasib (RMC-6236) — an investigational oral RAS inhibitor — in patients with previously treated metastatic pancreatic ductal adenocarcinoma.
Notably, the FDA received Revolution Medicines' expanded access application on April 28 and signed it just two days later on April 30. That rapid turnaround reflects the urgency the agency has placed on getting promising therapies to patients with this devastating diagnosis.
"Granting the request two days after receiving the expanded access application reflects the FDA's strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer."
— FDA Commissioner Dr. Marty Makary
Why This Drug Matters
Pancreatic cancer remains one of the most difficult cancers to treat. PDAC carries a five-year survival rate of only 3% for patients with advanced disease, and for those who have progressed after prior therapy, options have historically been extremely limited.
Daraxonrasib is a RAS(ON) inhibitor — it works by targeting RAS, the protein mutated in the vast majority of pancreatic cancer tumors. This is a class of drug that researchers have pursued for decades, and recent trial data represent a landmark in that effort.
13.2 Months median overall survival with daraxonrasib
6.7 Months median overall survival with chemotherapy
~2× Improvement in survival vs. standard of care
These results come from the Phase 3 RASolute 302 trial, announced April 13, 2026. In patients with pretreated metastatic pancreatic cancer, daraxonrasib nearly doubled median overall survival compared to chemotherapy. The full results are being presented in a plenary session at the 2026 ASCO Annual Meeting — underscoring the significance of this data to the oncology community.
The drug has also received FDA Breakthrough Therapy designation, Orphan Drug designation, and was selected for the FDA Commissioner's National Priority Voucher pilot program — all signals of the scientific and regulatory community's confidence in this treatment.
Our Practice Has Been Approved for EAP Access
Under the EAP, U.S.-licensed physicians may submit requests to Revolution Medicines on behalf of eligible patients who cannot participate in a clinical trial.
Our site has already been approved by the program and applicable regulatory authorities and have successfully ordered daraxonrasib for appropriate patients.
Who May Be Eligible
The EAP is specifically for patients with previously treated metastatic pancreatic ductal adenocarcinoma — meaning those who have received prior systemic therapy and whose disease has progressed. Eligibility will be determined on a case-by-case basis by our clinical team in accordance with the EAP protocol.
If you or a family member is being treated for metastatic PDAC at our practice and you have questions about whether this program may apply to you, please do not hesitate to contact our office. We encourage you to bring this up at your next appointment or call our care coordination team directly.
Looking Ahead
Revolution Medicines has indicated its intention to submit a New Drug Application (NDA) for daraxonrasib to the FDA — and the agency has flagged full approval as the highest priority. Formal approval could come as early as next year. Until then, the EAP represents the most direct path for eligible patients outside of a clinical trial to access this treatment.
We are proud to have moved quickly to make this option available to our patients. Advances like daraxonrasib represent the result of years of scientific effort and patient participation in trials, and it is our privilege to translate that science into care as swiftly as responsibly possible.
Questions About Your Eligibility?
If you are a current patient with metastatic pancreatic cancer and would like to discuss whether daraxonrasib through the EAP may be right for you, please contact our office. Our care team is here to walk you through the options.
.png)
.png)
