MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, or daraxonrasib, specifically for certain adult patients with metastatic pancreatic adenocarcinoma. This authorization was given on August 26, 2026, providing a novel targeted therapy option for individuals who have previously undergone systemic treatment. The authorization encompasses adults who have had at least one prior systemic therapy and includes those ineligible for multiagent systemic regimens. The drug was developed by Revolution Medicines and targets the RAS GTPase family.
This approval was based on data from RASolute 302, a Phase 3 trial involving 500 adults conducted across multiple centers. The study included participants with metastatic pancreatic adenocarcinoma that continued to advance after one line of systemic treatment. Researchers assigned 248 patients to receive daraxonrasib, while 252 were given standard chemotherapy selected by their physicians. The median overall survival was 13.2 months for the daraxonrasib group, compared to 6.7 months for those receiving chemotherapy. The FDA reported a hazard ratio for death of 0.40.
In addition to overall survival improvements, progression-free survival also showed significant gains. Median progression-free survival was 7.2 months with daraxonrasib, versus 3.6 months with standard chemotherapy. The objective response rate was 30% in the daraxonrasib group, compared to 11% in the chemotherapy cohort. These differences in survival and response rates were statistically significant, supporting the drug’s use for patients with metastatic disease who have already undergone systemic therapy.
Targeted therapy inhibits RAS pathway activity
Daraxonrasib functions as a RAS inhibitor, designed to interfere with active RAS proteins that promote tumor growth. Mutations in RAS genes are present in over 90% of pancreatic ductal adenocarcinomas. Patients take the medication orally at a dose of 300 milligrams once daily, continuing treatment until disease progression or intolerable side effects occur. The approval applies specifically to metastatic pancreatic adenocarcinoma and does not require the presence of a particular RAS mutation for prescribing.
Safety data indicated that adverse events were experienced by all patients in the Phase 3 trial receiving daraxonrasib. Grade 3 or higher adverse events affected 61.8% of those on daraxonrasib and 69.6% of patients on chemotherapy. Discontinuation due to treatment-related adverse events was seen in 1.2% of the daraxonrasib group and 11.2% of the chemotherapy group. Common side effects include rash, diarrhea, mucositis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also highlights several serious warnings and precautions.
Fast-tracked review process facilitated approval
The FDA’s review process incorporated several expedited programs for oncology drugs, such as Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency stated that it approved the application approximately 6.5 months ahead of its target date. The drug also received Breakthrough Therapy and Orphan Drug designations. Warnings include risks of skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Embryo-fetal toxicity is also noted. The review involved collaboration through Project Orbis, allowing other national regulators to participate. Health Canada was involved in the review, alongside observations from European and Japanese authorities. The FDA indicated that applications might still be under review elsewhere. This approval grants Revolution Medicines the authorization to market Rasonque for this specific U.S. patient population. The key Phase 3 trial demonstrated a median overall survival of 13.2 months versus 6.7 months with chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.