Rasonque Approval: First-in-Class RAS Therapy for Pancreatic Cancer
FDA approved daraxonrasib, sold as Rasonque, for certain adults with metastatic pancreatic adenocarcinoma after prior treatment or when multiagent therapy is unsuitable.
Timeline
- May 1, 2026: FDA permitted an expanded-access protocol for investigational daraxonrasib.
- August 26, 2026: FDA approved Rasonque for the specified metastatic pancreatic adenocarcinoma population.
- At approval: The recommended labeled dose was 300 mg by mouth once daily until progression or unacceptable toxicity.
The US Food and Drug Administration approved Rasonque, the brand name for daraxonrasib, on August 26, 2026. The indication covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. It is a prescription cancer treatment, and that wording does not cover every pancreatic tumor or every stage. [1][2]
Daraxonrasib inhibits the RAS GTPase family. RAS proteins help transmit growth signals inside cells, and altered RAS signaling drives many pancreatic adenocarcinomas. FDA described Rasonque as a first-in-class targeted therapy that acts against multiple forms of RAS. The designation refers to its mechanism and regulatory milestone, not a claim that it cures metastatic pancreatic cancer. [1][2]
The RASolute 302 trial randomly assigned 500 patients to daraxonrasib or a physician-selected standard chemotherapy regimen. It was open label and multicenter, and enrolled patients whose metastatic disease had progressed after one prior systemic treatment. FDA evaluated overall survival and progression-free survival through blinded independent review, both in patients with a RAS G12 mutation and in the full trial population. [2]
In the overall population, FDA reported median overall survival of 13.2 months with daraxonrasib and 6.7 months with standard chemotherapy. Median progression-free survival was 7.2 months versus 3.6 months, and objective response rates were 30 percent versus 11 percent. These are group medians from the trial; they cannot predict how long an individual patient will respond or live. [1][2]
The recommended dose in FDA's approval notice was 300 milligrams by mouth once daily until disease progression or unacceptable toxicity. The prescribing information includes warnings for skin and soft-tissue toxicity, mouth inflammation and other oral disorders, diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal harm. Treatment therefore requires oncology supervision and monitoring. [2]
FDA reviewed the drug through several expedited pathways, including breakthrough-therapy and orphan-drug designations, Real-Time Oncology Review and Project Orbis. The agency collaborated with Health Canada, while European and Japanese regulators participated as observers. A US approval does not automatically authorize the drug in those other jurisdictions, whose agencies make their own decisions. [1][2]
The approval's practical meaning is a new oral RAS-targeted choice for a defined group with metastatic disease, supported by a randomized comparison showing longer median survival. Patients should rely on the current prescribing information and their oncology team for eligibility, interactions and adverse-event management. Trial averages and a first-in-class label are useful context, but neither replaces an individualized medical decision. [1][2]
Sources
- FDA — First-in-class targeted therapy approved for metastatic pancreatic cancer
- FDA — Daraxonrasib approval, efficacy and safety details