Karmanos Now Offers FDA-Approved Daraxonrasib (Rasonque) for Metastatic Pancreatic Cancer

The Barbara Ann Karmanos Cancer Institute is now offering a new treatment for pancreatic cancer that will soon change how advanced disease is managed, after encouraging results from a phase III clinical trial and approval by the U.S. Food and Drug Administration (FDA) on Aug. 26, 2026. Karmanos was one of the institutions worldwide that contributed to FDA approval by conducting the RASolute 302 clinical trial at Karmanos Cancer Center in Detroit.

Daraxonrasib (RASONQUE, Revolution Medicines, Inc.), is approved for treating "adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy," as outlined by the FDA's news release.

"This means daraxonrasib is approved for patients with stage IV pancreatic cancer whose cancer progressed on previous chemotherapy, could not tolerate, or are not able to receive combination chemotherapy in the opinion of their treating oncologist," explained Najeeb Al Hallak, M.D., MS, medical oncologist, co-leader of the Gastrointestinal and Neuroendocrine Oncology Multidisciplinary Team (MDT) and member of the Phase I Clinical Trials MDT at Karmanos. Dr. Al Hallak served as the Karmanos leader for this international trial.

The study, known as RASolute 302, found that daraxonrasib helped patients with previously treated stage IV pancreatic cancer live longer than those who received standard chemotherapy.

"Daraxonrasib, an oral tablet taken once a day, targets active forms of the RAS family of proteins, which are key drivers of tumor growth in most pancreatic adenocarcinomas," added Dr. Al Hallak.

The National Cancer Institute estimates that 67,530 new cases of pancreatic cancer will be diagnosed in the U.S. in 2026. Approximately 51% are diagnosed after the cancer has spread to distant parts of the body, limiting treatment options.

In the randomized phase III RASolute 302 trial involving 500 participants, the median overall survival from the start of the second-line study treatment was 13.2 months with daraxonrasib, compared to 6.7 months with standard chemotherapy. This means half the patients treated with daraxonrasib lived longer than 13.2 months, and half lived less.

Severe side effects occurred in 61.8% of patients receiving daraxonrasib and 69.6% receiving chemotherapy. Treatment-related adverse events led to discontinuation in 1.2% and 11.2% of patients, respectively. Daraxonrasib carries warnings for several potentially serious adverse reactions, and patients should discuss its possible benefits and risks with their treating oncologist.

Karmanos Cancer Institute remains committed to advancing pancreatic cancer treatment to further improve outcomes for all patients with this aggressive disease.

Learn more about the Gastrointestinal and Neuroendocrine Oncology Multidisciplinary Team.