MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized the use of Rasonque, also known as daraxonrasib, for certain adults diagnosed with metastatic pancreatic adenocarcinoma. The agency approved the once-daily oral tablet on August 26, 2026, providing a new targeted option for patients. This approval applies to adults who have previously undergone at least one systemic therapy and includes those ineligible for multiagent systemic treatment. The drug was developed by Revolution Medicines and specifically targets the RAS GTPase family.
The authorization was based on data from RASolute 302, a Phase 3 trial that was randomized, multicenter, and open-label, involving 500 adult participants. All had metastatic pancreatic adenocarcinoma that had advanced following one prior systemic therapy. Researchers randomized 248 patients to receive daraxonrasib and 252 to receive standard chemotherapy selected by their physicians. The median overall survival was 13.2 months for those treated with daraxonrasib, compared to 6.7 months in the chemotherapy group. The FDA reported a hazard ratio for death of 0.40.
In addition, progression-free survival was notably improved across the entire study population. Patients on daraxonrasib experienced a median progression-free survival of 7.2 months, whereas those on standard chemotherapy had a median of 3.6 months. The objective response rate was 30% for the daraxonrasib group, versus 11% in the chemotherapy cohort. These differences in overall survival, progression-free survival, and response rate were deemed statistically significant. Overall, the findings endorse the use of the drug in patients with metastatic disease that has already been treated with systemic therapy.
Targeted medication inhibits RAS pathway activity
Designed as a RAS inhibitor, daraxonrasib aims to block active RAS proteins that promote tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. Patients take the medication orally at a recommended dose of 300 milligrams daily, continuing until disease progression or unacceptable side effects occur. The FDA’s approval covers metastatic pancreatic adenocarcinoma and does not require the presence of a specific RAS mutation for prescribing.
Safety data indicated that adverse events were experienced by all patients in the Phase 3 trial. Grade 3 or higher adverse events occurred in 61.8% of those receiving daraxonrasib and 69.6% of the chemotherapy group. Treatment discontinuation due to adverse events occurred in 1.2% of the daraxonrasib patients, compared to 11.2% in the chemotherapy group. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also highlights several serious warnings and precautions.
FDA expedited review under priority programs
Notable warnings include toxicity to skin and soft tissues, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Additionally, the label warns of embryo-fetal toxicity. The FDA’s review process involved several accelerated oncology programs, such as Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency indicated it approved the application approximately 6.5 months ahead of the target date. Daraxonrasib has also received Breakthrough Therapy and Orphan Drug designations.
The review was conducted through Project Orbis, facilitating collaboration with other international regulatory agencies on oncology submissions. Health Canada participated in the review process, while European and Japanese regulators observed as official partners. The FDA noted that other agencies may still be reviewing the application. This approval grants Revolution Medicines the authorization for Rasonque in this specific U.S. patient group. The pivotal Phase 3 result showed a median overall survival of 13.2 months for patients on daraxonrasib, versus 6.7 months with chemotherapy in those previously treated for metastatic pancreatic adenocarcinoma.