MARYLAND / RankWire.AI / – In the United States, the U.S. Food and Drug Administration approved Rasonque, or daraxonrasib, specifically for adult patients with metastatic pancreatic adenocarcinoma. The agency announced this decision on August 26, 2026. This authorization is applicable to individuals who have previously undergone at least one systemic therapy. It also encompasses adults ineligible for multiagent systemic treatment. Revolution Medicines developed this oral medication targeting the RAS GTPase family, with patients advised to take a standard dose of 300 milligrams once daily.
The approval was based on results from the Phase 3 RASolute 302 trial, which included 500 adult participants with metastatic pancreatic adenocarcinoma. All had experienced disease progression following one prior systemic treatment. Researchers assigned 248 patients to daraxonrasib and 252 to chemotherapy chosen by their physicians. The median overall survival was 13.2 months for those treated with daraxonrasib, compared to 6.7 months for the chemotherapy group. The trial showed a hazard ratio for death of 0.40, indicating a significant benefit with daraxonrasib.
Additional key outcomes demonstrated the effectiveness of daraxonrasib. The median progression-free survival reached 7.2 months in the treatment group, whereas the chemotherapy cohort had 3.6 months. The objective response rate was 30% with daraxonrasib, significantly higher than the 11% observed with chemotherapy. Statistically meaningful differences were identified in overall survival, progression-free survival, and response rate, which collectively supported the U.S. approval for this previously treated metastatic pancreatic cancer indication.
Clinical trial findings underpin targeted therapy approval
Daraxonrasib functions by inhibiting active RAS proteins, which can promote tumor growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. Importantly, the prescribing information does not mandate that patients possess a specific RAS mutation to qualify for this treatment. The medication is administered until disease progression or intolerable side effects occur. Revolution Medicines created Rasonque as an oral agent offering a targeted option for this defined patient group, expanding treatment options following initial systemic therapies.
The Phase 3 trial also evaluated safety outcomes related to the treatment. Grade 3 or higher adverse events occurred in 61.8% of patients treated with daraxonrasib, compared to 69.6% in the chemotherapy group. Treatment discontinuation due to adverse events was reported in 1.2% of daraxonrasib patients, versus 11.2% in the chemotherapy arm. Common side effects included rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, reduced appetite, edema, mouth inflammation, and bleeding.
International regulatory cooperation influenced FDA review process
The prescribing information for Rasonque includes warnings for serious risks such as skin and soft tissue toxicity, oral issues, severe diarrhea, and gastrointestinal perforation. It also notes potential for interstitial lung disease or pneumonitis and embryo-fetal toxicity. The FDA utilized expedited review pathways for oncology drugs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, completing the approval approximately 6.5 months ahead of its regulatory target date.
The agency also assessed the application through Project Orbis, which facilitates coordinated reviews among international cancer regulators. Health Canada participated in the review process. European and Japanese regulators observed as official partners. Additionally, daraxonrasib obtained Breakthrough Therapy and Orphan Drug designations in the United States. This approval provides eligible U.S. patients with access to Rasonque after previous systemic therapy or when multiagent treatment is unsuitable. The Phase 3 trial demonstrated a median overall survival of 13.2 months, notably higher than the 6.7 months seen with chemotherapy.