FDA Approves Daraxonrasib as First RAS Inhibitor for Pancreatic Cancer
Daraxonrasib is approved for previously treated or systemic-therapy-ineligible metastatic pancreatic adenocarcinoma.
The U.S. Food and Drug Administration (FDA) has approved daraxonrasib (Rasonque) for adults with metastatic pancreatic adenocarcinoma whose cancer has progressed following at least one prior line of systemic therapy or who cannot receive multiagent systemic therapy.
Daraxonrasib inhibits the RAS family of proteins, mutant forms of which drive most cases of pancreatic cancer. Daraxonrasib is an example of a molecular glue, a type of treatment that brings proteins together to alter their function. Daraxonrasib works by bridging RAS with another protein called cyclophilin A. This inhibits RAS’ ability to trigger cancer-promoting processes by blocking its interaction with other signaling proteins.
This is the first FDA approval for daraxonrasib, which is the first RAS inhibitor to be approved for pancreatic cancer. Other RAS inhibitors have been approved to treat certain lung cancers and colorectal cancers that harbor a particular mutant form of RAS known as KRAS G12C. However, these inhibitors are not approved to treat pancreatic cancers, the majority of which are driven by a different RAS mutant. Because daraxonrasib does not target a specific mutation, it may be effective against different wild-type and mutant RAS proteins, making it the first pan-RAS inhibitor to be approved for any cancer type.
Preclinical data and early clinical data on daraxonrasib were published in Cancer Discovery, a journal of the American Association for Cancer Research (AACR), in 2024.
The approval was based on results from RASolute 302, a randomized, open-label, multicenter phase III clinical trial. The trial enrolled 500 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed after one prior line of systemic therapy. Patients were randomly assigned on a 1:1 basis to receive either daraxonrasib or a physician’s choice of standard-of-care chemotherapy.
After a median 8.5 months of follow-up, the patients in the daraxonrasib arm experienced significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared with patients in the chemotherapy arm.
The median OS in the daraxonrasib arm was 13.2 months versus 6.7 months in the chemotherapy arm, which translated to a 60% lower risk of death among patients treated with daraxonrasib. The median PFS was 7.2 months in the daraxonrasib arm versus 3.6 months in the chemotherapy arm. And the ORR in the daraxonrasib arm was 30%, compared with 11% in the chemotherapy arm.
The recommended dose for daraxonrasib is 300 mg administered daily via oral tablets until disease progression or unacceptable toxicity.
Pancreatic cancer, which typically forms in the ducts of the pancreas as pancreatic ductal adenocarcinoma, is one of the deadliest forms of cancer: The five-year relative survival rate remains just 13.7%. According to federal statistics, it was estimated that 67,530 individuals would be diagnosed with pancreatic cancer and 52,740 patients would die of the disease in the United States in 2026.
The FDA rendered its decision on August 26, 2026. Check this resource for updated information on all therapeutics regulated by the FDA.