Detroit, Michigan, August 31, 2026
The Barbara Ann Karmanos Cancer Institute announced that it is now offering FDA-approved daraxonrasib (RASONQUE) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The treatment received U.S. Food and Drug Administration (FDA) approval on August 26, 2026, following results from the Phase 3 RASolute 302 clinical trial. Karmanos was among the institutions participating in the international study and conducted the trial at its cancer center in Detroit.
Daraxonrasib Shows Survival Benefit in Phase 3 Trial
The FDA approval was supported by findings from the randomized Phase 3 RASolute 302 trial, which enrolled 500 participants with previously treated stage IV pancreatic cancer. According to Karmanos, the study demonstrated that patients treated with daraxonrasib experienced longer overall survival than those receiving standard chemotherapy. Median overall survival was 13.2 months with daraxonrasib compared with 6.7 months with standard chemotherapy, representing a substantial difference in survival from the beginning of second-line treatment. Daraxonrasib is an oral, once-daily tablet designed to target active forms of RAS proteins, which are important drivers of tumor growth in pancreatic adenocarcinoma. The treatment represents a targeted approach to a disease in which advanced-stage patients frequently have limited therapeutic options after progression on initial treatment. Karmanos medical oncologist Najeeb Al Hallak, M.D., MS, who served as the institute’s leader for the international RASolute 302 trial, said the approval applies to patients with stage IV pancreatic cancer whose disease has progressed following previous chemotherapy or who cannot tolerate or receive combination chemotherapy, based on their treating oncologist’s assessment.
Karmanos Played Role in RASolute 302 Trial
The availability of daraxonrasib at Karmanos has particular significance because the cancer institute participated directly in the clinical research that contributed to the treatment’s FDA approval. The institute’s involvement reflects its continuing role in conducting clinical trials designed to evaluate new cancer therapies and move promising treatments toward patient care. Pancreatic cancer remains a major oncology challenge, particularly when diagnosed after it has spread to distant organs. Karmanos cited National Cancer Institute estimates indicating that 67,530 new pancreatic cancer cases are expected in the United States in 2026, with approximately 51% diagnosed after distant spread. Metastatic disease substantially limits treatment options and underscores the need for new therapies capable of extending survival. The RASolute 302 findings provide evidence supporting daraxonrasib as a new treatment option for eligible patients with previously treated metastatic pancreatic adenocarcinoma. The therapy’s oral administration also provides a different treatment format from many intravenous chemotherapy regimens, although treatment selection and suitability remain dependent on individual patient circumstances.
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Safety Profile Supports Clinical Use
In the Phase 3 study, severe adverse events occurred in 61.8% of patients receiving daraxonrasib compared with 69.6% of patients receiving chemotherapy. Treatment-related adverse events led to treatment discontinuation in 1.2% of patients receiving daraxonrasib versus 11.2% of those receiving chemotherapy. Karmanos also emphasized that daraxonrasib carries warnings for potentially serious adverse reactions and that patients should discuss the potential benefits and risks with their treating oncologist. The availability of RASONQUE at Karmanos marks an important transition from clinical research to patient treatment. The institute’s participation in RASolute 302 demonstrates how clinical trial infrastructure can contribute to bringing new targeted therapies into oncology practice. For patients with metastatic pancreatic adenocarcinoma whose disease has progressed after systemic therapy, daraxonrasib provides a newly approved treatment option targeting a key molecular pathway involved in tumor growth. The FDA approval and subsequent clinical availability at Karmanos represent a significant development in the continuing effort to improve outcomes for people affected by this aggressive cancer.
Source: Karmanos Cancer Institute press relese
