FDA Approves Daraxonrasib (Rasonque) — First RAS-Targeted Therapy for Metastatic Pancreatic Cancer
On Aug 26, 2026 the FDA approved Rasonque (daraxonrasib), Revolution Medicines' first-in-class RAS inhibitor for metastatic pancreatic cancer; trial survival was 13.2 vs 6.7 months.
A first strike at 'undruggable' RAS in pancreatic cancer
The FDA on August 26, 2026 approved Rasonque (daraxonrasib), a first-in-class oral RAS inhibitor from Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy or for those unable to tolerate multiagent chemotherapy. RAS mutations drive tumor growth in most pancreatic adenocarcinomas, and no approved therapy had directly targeted them in this disease before.[1][3][4]
The decision landed roughly 6.5 months ahead of the agency's user fee deadline. Acting FDA Commissioner Kyle Diamantas called the approval 'a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.'[1][2]
The evidence: RASolute 302
Approval rested on the Phase 3 RASolute 302 trial, a randomized, open-label, multicenter study of about 500 previously treated patients. Daraxonrasib delivered median overall survival of 13.2 months versus 6.7 months for chemotherapy — a near-doubling in a cancer where pancreatic adenocarcinoma makes up 90-95% of diagnoses and five-year survival hovers near 13%. The once-daily RAS(ON) multi-selective tablet now becomes a new standard option in the second-line setting.[1][2][4]
Verified facts
Cross-checked against 2+ independent sourcesThis section contains facts cross-checked against multiple sources.
On August 26, 2026, the FDA approved Rasonque (daraxonrasib), developed by Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.[1][2][3] 3 sources
Daraxonrasib is the first approved therapy that directly targets RAS proteins in pancreatic cancer — mutations that drive tumor growth in the large majority of pancreatic adenocarcinoma patients.[1][4] 2 sources
In the Phase 3 RASolute 302 trial, daraxonrasib extended median overall survival to 13.2 months versus 6.7 months for chemotherapy in previously treated metastatic pancreatic adenocarcinoma — roughly a doubling of survival.[1][2][4] 3 sources
The approval came about 6.5 months ahead of the FDA's user fee (PDUFA) deadline for the application.[1][2] 2 sources
Rasonque is an oral, once-daily RAS(ON) multi-selective inhibitor taken as a tablet.[1][2] 2 sources
Reported, not confirmed
Not cross-checked — do not read as factFrom here on: claims and speculation that are not cross-checked.
The pivotal trial was a randomized, open-label, multicenter study enrolling about 500 adults with previously treated metastatic pancreatic adenocarcinoma.[1] single-source ×1 · FDA press announcement
Pancreatic adenocarcinoma accounts for roughly 90-95% of US pancreatic cancer diagnoses, and the disease's five-year survival rate is about 13%.[2] single-source ×1 · BioSpace, citing disease background statistics
Acting FDA Commissioner Kyle Diamantas said the approval 'provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.'[2] single-source ×1 · FDA statement quoted by BioSpace
Daraxonrasib had earlier received FDA orphan drug designation for pancreatic cancer, and its New Drug Application was accepted for priority review before the early approval.[2] single-source ×1 · Revolution Medicines regulatory history as reported in trade press
Timeline
- 2026-08-26
FDA approves Rasonque (daraxonrasib) for previously treated metastatic pancreatic adenocarcinoma, about 6.5 months before the user fee deadline.[1][2]
- 2026-08-26
Revolution Medicines and national outlets announce the approval; FDA calls it a first-in-class targeted therapy for the disease.[3][4]
Outcome
- Model
- claude-opus-5
- Time
- 08/27/2026, 02:30
- Tokens
- 8,000
- Sources
- 5 sources adopted
- Model
- claude-opus-5 (review pass)
- Time
- 08/27/2026, 02:30
- Tokens
- 3,000
- Verdict
- Passed
| 08/27/2026, 02:30 | First authored (claude-opus-5) | Created |
| 08/27/2026 | First authored | Updated |
Frequently asked
Why is the daraxonrasib approval considered historic?
It is the first approved medicine that directly targets RAS, the mutated protein family that drives most pancreatic adenocarcinomas. RAS was long considered 'undruggable,' and pancreatic cancer has had few effective options, with a five-year survival rate around 13%.
How effective was the drug in trials?
In the Phase 3 RASolute 302 trial of previously treated metastatic pancreatic adenocarcinoma, daraxonrasib roughly doubled median overall survival: 13.2 months versus 6.7 months with standard chemotherapy.
Who is eligible for Rasonque?
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 taken as a once-daily oral tablet.
Official links
- Official FDA — Press Announcements
- Official Revolution Medicines — Investor Relations news
Sources
- [1] FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer primary
- [2] RevMed receives early FDA approval for 'groundbreaking' pancreatic cancer drug
- [3] Revolution Medicines gets FDA nod for targeted pancreatic cancer drug
- [4] FDA Approves RevMed's Breakthrough Pill for Pancreatic Cancer
- [5] FDA Approves Daraxonrasib for Metastatic Pancreatic Adenocarcinoma