MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration granted approval to Rasonque, also known as daraxonrasib, specifically for certain adult patients diagnosed with metastatic pancreatic adenocarcinoma. The FDA made this decision public on August 26, 2026. This authorization covers individuals who have previously undergone at least one systemic therapy and those unable to receive multiagent systemic treatments. Revolution Medicines is responsible for developing this oral medication, which specifically targets the RAS GTPase family. Patients are advised to take the medication at a dosage of 300 milligrams once every day.
The approval was based on results from the Phase 3 RASolute 302 trial, which enrolled 500 adults with metastatic pancreatic adenocarcinoma that had advanced following one prior systemic therapy. Researchers randomized 248 patients to receive daraxonrasib and 252 to the physician-selected chemotherapy. The median overall survival was 13.2 months for those treated with daraxonrasib. In comparison, patients receiving chemotherapy had a median overall survival of 6.7 months. The trial reported a hazard ratio for death of 0.40, highlighting a significant benefit of the targeted therapy over standard chemotherapy.
In addition to extending survival, daraxonrasib demonstrated improvements in other key clinical endpoints. The median progression-free survival was 7.2 months for patients on daraxonrasib, whereas it was only 3.6 months for those on chemotherapy. The objective response rate with daraxonrasib reached 30%, compared to 11% with chemotherapy. The study showed statistically meaningful differences across overall survival, progression-free survival, and response rate, providing robust evidence that supported the FDA’s decision to approve the drug for this patient group.
Clinical trial findings underpin the approval of this targeted therapy
Daraxonrasib functions by blocking active forms of RAS proteins, which are known to promote cancer cell growth. Mutations in RAS genes are present in over 90% of pancreatic ductal adenocarcinomas. Interestingly, the prescribing details do not mandate that patients possess a specific RAS mutation for treatment with daraxonrasib. The medication is administered until disease progression or unacceptable adverse effects occur. Revolution Medicines created Rasonque as an oral option tailored for this defined patient population, offering a targeted alternative following initial systemic therapy.
The Phase 3 trial also evaluated safety outcomes related to treatment. Serious adverse events classified as Grade 3 or higher affected 61.8% of patients receiving daraxonrasib, while the rate was higher at 69.6% among those treated with chemotherapy. Discontinuation due to treatment-related adverse effects was observed in 1.2% of daraxonrasib patients, compared to 11.2% in the chemotherapy group. Typical side effects include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, loss of appetite, edema, mouth inflammation, and bleeding.
International regulatory efforts contributed to FDA approval process
The prescribing information for Rasonque highlights warnings concerning several serious risks. These encompass skin and soft tissue toxicity, oral disorders, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The FDA utilized expedited review pathways for oncology drugs, such as the Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, during its evaluation of the application. The agency indicated that it finalized the approval approximately 6.5 months prior to its established regulatory deadline.
Furthermore, the FDA reviewed the application through Project Orbis, an initiative promoting collaborative assessment among international cancer regulators. Health Canada participated in the review process, alongside official observers from European and Japanese regulatory bodies. Additionally, daraxonrasib has earned both Breakthrough Therapy and Orphan Drug designations within the United States. The approval grants eligible U.S. patients access to Rasonque post prior systemic therapy or when multiagent treatment is unsuitable. The Phase 3 trial results showed a median overall survival of 13.2 months compared with 6.7 months for those on chemotherapy, supporting its clinical benefit.