Revolution Medicines' Daraxonrasib Succeeds in Phase 3 Pancreatic Cancer Trial

Revolution Medicines reported positive results from a Phase 3 clinical trial of its drug daraxonrasib for pancreatic cancer. The trial involved patients whose cancer had progressed after previous treatment. Daraxonrasib, administered as a daily pill, met all primary and secondary endpoints.

7 months for those receiving chemotherapy. 5 months in survival time. The drug also reduced the risk of death by 60% relative to chemotherapy. Pancreatic cancer is an aggressive disease with a five-year survival rate of 13%, the lowest among major cancers.

The disease often involves RAS mutations, which drive tumor growth and occur in about 90% of cases. Daraxonrasib targets these RAS mutations broadly.

The trial evaluated daraxonrasib as a second-line treatment for patients whose cancer had spread despite prior therapy.

Revolution Medicines described the drug's safety profile as manageable, with no new concerns observed. Common side effects include rash, which is generally treatable. Former Republican Sen. Ben Sasse shared his experience with rash as a side effect in an interview with The New York Times.

Revolution Medicines noted that it cannot comment on individual patients but confirmed rash as a known, manageable effect. The company is conducting a separate Phase 3 trial for daraxonrasib in newly diagnosed pancreatic cancer patients. This ongoing study aims to assess the drug's efficacy in first-line treatment settings.

Medicines plans to submit daraxonrasib for FDA approval soon, utilizing a Commissioner's National Priority Voucher.

This voucher allows for an expedited review process, potentially within months. Approval would provide a new oral treatment option beyond traditional intravenous chemotherapy. Historically, pancreatic cancer treatment has relied primarily on cytotoxic chemotherapy.

The trial results indicate daraxonrasib could offer an alternative targeting the underlying genetic drivers of the disease. Patients with advanced pancreatic cancer currently face limited effective options after initial treatments fail. Following the announcement, Revolution Medicines' shares increased by more than 30%.

The results were released on Monday, April 13, 2026. The company emphasized the urgency of bringing the drug to patients in need.

“These are dramatic, practice-changing outcomes, and our focus now is moving quickly to bring this potential new treatment option to patients who urgently need new treatment.”

Mark Goldsmith, CEO of Revolution Medicines, stated that no prior drug has demonstrated an overall survival benefit exceeding one year in a Phase 3 pancreatic cancer trial. He described the results as introducing a new era of RAS-targeted therapies for the disease. The company aims to advance the drug through regulatory processes efficiently.