FDA Approves First RAS-Targeted Pancreatic Cancer Drug
People with advanced pancreatic cancer have a new treatment option. On August 26, 2026, the U.S. Food and Drug Administration approved daraxonrasib, sold as Rasonque by Revolution Medicines, according to the FDA. It is for adults with metastatic pancreatic adenocarcinoma who have already had at least one earlier systemic treatment, or who cannot receive multi-drug therapy.
The medicine is taken by mouth once a day. It blocks signals from RAS proteins, the main pathway that drives this cancer. More than 90% of patients carry cancer-driving mutations in the KRAS gene, according to Dana-Farber Cancer Institute, and daraxonrasib is the first approved targeted therapy for pancreatic cancer designed to inhibit RAS.
Dana-Farber's Dr. Brian Wolpin led the phase 3 RASolute 302 trial, which enrolled 500 patients in North America, Europe and Asia. People who took daraxonrasib lived a median of 13.2 months, compared with 6.7 months for those who received chemotherapy. The median time before the cancer grew again was 7.2 months, versus 3.6 months. Wolpin said the near doubling of median survival marks meaningful progress for patients who urgently need new options.
The FDA cleared the drug about 6.5 months ahead of its goal date. The most common side effects in the trial were rash, mouth inflammation, nausea and diarrhea, and the label includes warnings such as lung inflammation. Anyone affected should talk with their cancer care team about whether this treatment is right for them.
For one of the hardest cancers to treat, that extra time is real progress.
