FDA Approves Rasonque, New Targeted Drug That Nearly Doubled Survival In Pancreatic Cancer Trial
The US Food and Drug Administration (FDA) has approved a new targeted treatment for adults with metastatic pancreatic cancer, giving patients with one of the most difficult-to-treat forms of the disease another treatment option.
The drug, daraxonrasib, will be marketed in the US under the brand name Rasonque and was developed by Revolution Medicines. The FDA approved the once-daily oral medicine on August 26 for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
The approval is based on results from RASolute 302, a global Phase 3 clinical trial involving 500 patients with metastatic pancreatic ductal adenocarcinoma whose disease had progressed after one previous line of systemic treatment. Patients were randomly assigned to receive either daraxonrasib or physician’s choice of standard chemotherapy.
What did the trial find?
The results showed a significant survival benefit for patients receiving daraxonrasib. In the overall trial population, the median overall survival was 13.2 months with daraxonrasib, compared with 6.7 months with standard chemotherapy. The hazard ratio for death was 0.40, meaning the relative risk of death was 60% lower in the daraxonrasib group during the study period.
The drug also improved progression-free survival. Patients receiving daraxonrasib had a median progression-free survival of 7.2 months, compared with 3.6 months among those receiving chemotherapy. The objective response rate was 30% with daraxonrasib versus 11% with chemotherapy.
The findings were published in The New England Journal of Medicine in May and later appeared in the journal’s July 2026 issue.
How does Rasonque work?
Daraxonrasib belongs to a new class of medicines designed to inhibit the RAS GTPase family, a group of proteins involved in signalling that can drive cancer-cell growth.
RAS signalling is particularly important in pancreatic ductal adenocarcinoma. According to the FDA, Rasonque targets multiple forms of RAS, a key driver of tumour growth in most pancreatic adenocarcinomas.
This makes the approval significant because it introduces a targeted treatment approach for metastatic pancreatic cancer rather than relying solely on conventional chemotherapy.
However, the drug does not cure pancreatic cancer. The FDA approval is specifically for metastatic disease in adults who meet the stated treatment criteria, and the survival figures from the trial represent median outcomes across the study population, they do not predict how long an individual patient will live.
What are the side effects?
The FDA lists several common adverse reactions associated with Rasonque, including rash, diarrhoea, stomatitis, nausea, fatigue, vomiting, abdominal pain, swelling or oedema, decreased appetite and haemorrhage. The prescribing information also includes warnings and precautions concerning dermatologic and soft-tissue toxicity, oral disorders, gastrointestinal complications, interstitial lung disease/pneumonitis and embryo-fetal toxicity.
In the RASolute 302 trial, adverse events occurred in all patients receiving daraxonrasib and in 97.7% of those receiving chemotherapy. Grade 3 or higher adverse events occurred in 61.8% of the daraxonrasib group and 69.6% of the chemotherapy group.
What makes the approval significant?
Pancreatic cancer remains challenging to treat because it is frequently diagnosed after it has already spread. The new approval does not change that reality, but it does add a targeted medicine that demonstrated a meaningful survival advantage over standard chemotherapy in a Phase 3 trial.
The FDA described the approval as a new treatment option for patients facing an “extraordinarily difficult and historically hard-to-treat cancer." The agency also said the application was reviewed under its National Priority Voucher pilot programme and that approval came 6.5 months before the user-fee deadline.
The treatment is now available by prescription in the United States. Revolution Medicines reported a wholesale acquisition cost of $39,800 for a 30-day supply at the recommended dose.
For now, the significance of Rasonque is best understood not as a cure for pancreatic cancer, but as a new targeted treatment that substantially improved median survival compared with chemotherapy in a Phase 3 trial of previously treated metastatic disease. Further studies are also evaluating daraxonrasib in other treatment settings, including earlier lines of therapy.