The FDA has approved Rasonque (daraxonrasib), a first-in-class targeted therapy for metastatic pancreatic cancer, clearing the regulatory hurdle more than six months ahead of its scheduled date.
Rasonque is a once-daily tablet that targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma. The therapy works by suppressing RAS signaling through the inhibition of the interaction between both wild-type and mutant RAS(ON) proteins.
Developed by Revolution Medicines, the drug is available now for a wholesale acquisition cost of $39,800 for a 30-day supply. Commercially insured patients may be eligible for $0 co-pay through the company’s (On)Path program. Company officials said during an investor call that they anticipate insurer discounts to be about 20% to 30%. Additionally, they expect that most patients will be covered through Medicare Part D.
Survival data from trials
The approval was based on data from the phase 3 RASolute 302 study, an open-label clinical trial that enrolled 500 adults with previously treated metastatic pancreatic adenocarcinoma. Rasonque reduced the risk of death by 60% and demonstrated an overall survival benefit compared with chemotherapy, with statistically significant and clinically meaningful improvements across all primary and key secondary endpoints.
Related: 6 Signs You May Benefit from Facial Rejuvenation
Rasonque improved median overall survival to 13.2 months compared with 6.7 months for standard chemotherapy. The difference in progression-free survival was similar: a median of 7.3 months in the daraxonrasib group compared with 3.5 months in the chemotherapy group.
While the numbers show a significant jump in survival time, the underlying biology of pancreatic cancer creates a difficult environment for treatment. Because the disease often presents in later stages due to a lack of early symptoms, patients frequently begin care after the cancer has spread. The National Cancer Institute’s Surveillance, Epidemiology and End Results Program (SEER) estimates 67,530 new cases this year, with about 52,740 deaths, reflecting a five-year survival rate of just 13.7%. Early diagnosis before the cancer has spread increases the survival rate to 43.6%, highlighting the gap that successful therapies must bridge.
Side effects of Rasonque include dermatologic and soft tissue toxicity, stomatitis and oral disorders, diarrhea, gastrointestinal perforation, interstitial lung disease/pneumonitis, and embryo-fetal toxicity. The most common adverse events are rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. Treatment-related adverse events that led to treatment discontinuation occurred in 1.2% of the patients in the daraxonrasib group and in 11.2% of those in the chemotherapy group.
Data from the RASolute 302 trial were presented in May 2026 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and published in The New England Journal of Medicine on May 31, 2026.
