FDA Authorizes Expanded Access for RAS(ON) Inhibitor After Survival Boost

The U.S. Food and Drug Administration (FDA) has authorized an expanded access treatment protocol for daraxonrasib, an experimental oral medication designed to treat patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The agency issued a safe to proceed letter to the drug’s sponsor, Revolution Medicines, on May 1, 2026.

Expanded access, often referred to as compassionate use, allows patients with serious or life-threatening conditions to access investigational therapies outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Clinical Trial Results and Survival Data

The FDA’s decision follows the release of topline results from the RASolute 302 trial, a global, randomized, open-label Phase 3 study. The trial compared the efficacy of daraxonrasib against standard-of-care chemotherapy in patients with metastatic pancreatic cancer who had undergone previous treatment.

According to reporting from CBS News, patients who received the drug in the clinical trial survived a median of 13 months. In comparison, patients who received standard chemotherapy survived a median of about six months.

The drug is described as a RAS(ON) multi-selective inhibitor. This mechanism of action targets a specific signal that causes cancer cells to grow continuously. Revolution Medicines reported that the drug nearly doubled median overall survival (OS) compared to chemotherapy, which represents one of the most pronounced survival separations recorded in a randomized pancreatic cancer trial.

Treatment Administration and Protocol

Daraxonrasib is administered as an oral pill. While the RASolute 302 trial evaluated a dose of 300 mg taken once daily, other reports indicate the medication may be taken three times a day depending on the protocol.

The expanded access program is specifically intended for patients with previously treated metastatic pancreatic ductal adenocarcinoma. This provides a pathway for patients who may not meet the strict eligibility criteria for ongoing clinical trials but have exhausted other standard treatment options.

Medical Context of Metastatic PDAC

Pancreatic ductal adenocarcinoma is the most common form of pancreatic cancer and is characterized by a high degree of aggressiveness. When the cancer becomes metastatic, meaning it has spread to other parts of the body, treatment options are typically limited to chemotherapy and supportive care.

The focus on RAS(ON) inhibitors stems from the fact that mutations in the RAS gene are present in the vast majority of pancreatic cancers. By inhibiting the active or ON state of these proteins, researchers aim to shut down the signaling pathways that drive tumor growth, and proliferation.

The RASolute 302 trial (NCT06625320) began in October 2024 and is expected to continue until approximately December 2027. While the topline results have shown significant survival benefits, the drug remains an investigational product and has not yet received full FDA approval for general commercial use.