FDA Grants Early Access to Pancreatic Cancer Drug Daraxonrasib

The U.S. Food and Drug Administration (FDA) has issued a safe to proceed letter to Revolution Medicines, granting expanded access authorization for the investigational drug daraxonrasib. This authorization allows the company to initiate an expanded access treatment protocol (EAP) for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

Expanded access is a regulatory pathway designed for patients with serious or life-threatening conditions who cannot participate in a clinical trial and have exhausted all other appropriate treatment options. The decision follows the release of Phase III clinical trial data indicating that the drug may significantly extend the lives of those with one of the most difficult-to-treat forms of cancer.

Clinical Trial Results and Survival Rates

According to data released by Revolution Medicines on April 13, 2026, daraxonrasib demonstrated a marked improvement in overall survival compared to standard chemotherapy. In a global, randomized trial involving more than 60 locations, the drug showed a median overall survival of 13.2 months, compared to 6.7 months for patients receiving chemotherapy.

Overall survival is defined as the length of time from the start of treatment until death from any cause. The results suggest that the therapy approximately doubles the survival time for patients with previously treated metastatic pancreatic cancer.

Revolution Medicines stated that the drug was generally well tolerated and maintained a manageable safety profile with no new safety signals identified during the study.

Targeting the RAS Mutation

Daraxonrasib is a once-daily pill that targets RAS mutations, which are present in more than 90% of patients with pancreatic adenocarcinoma, the most common type of pancreatic cancer. For decades, the RAS protein was considered undruggable by the scientific community because there was no known effective way to target it.

The ability to target these mutations represents a shift in the treatment of pancreatic cancer, which has historically seen low survival rates. By inhibiting the RAS(ON) state, the drug aims to stop the growth of cancer cells that depend on these mutated proteins to survive and proliferate.

“We are standing at the threshold of groundbreaking treatments for patients with pancreatic cancer. Today’s announcement represents a real opportunity to bring new hope for people facing this disease: hope for more time with family, hope for better quality of life and hope that ongoing and future research may ultimately lead to a cure.”

Anna Berkenblit, M.D., MMSc., Chief Scientific and Medical Officer of PanCAN

Next Steps for Patient Access

While the expanded access program provides a bridge for some patients, the drug is not yet fully approved for general clinical use. Revolution Medicines intends to submit the Phase III data to the FDA to seek formal approval for daraxonrasib as a treatment for patients with metastatic pancreatic adenocarcinoma who have undergone previous treatment.

In response to the FDA’s authorization, Revolution Medicines stated that the move represents a critical step in the process of opening an EAP and noted that the company is working to ensure safe and equitable access for eligible patients in the United States.

Patients interested in the expanded access program must submit a request through a licensed treating physician according to the company’s policy.