FDA Approves Daraxonrasib (Rasonque) — First-in-Class 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-in-class RAS inhibitor for 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. The FDA called it a first-in-class targeted therapy: the once-daily tablet targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma.[1][3]
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
Each fact is labelled with its evidence typeEach fact in this section carries its evidence type — either cross-checked against independent sources, or confirmed from a single authoritative record.
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 · independent
The FDA described Rasonque (daraxonrasib) as a first-in-class targeted therapy; the tablet targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma.[1][3] 2 sources · independent
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 · independent
The approval came about 6.5 months ahead of the FDA's user fee (PDUFA) deadline for the application.[1][2] 2 sources · independent
Rasonque is an oral, once-daily RAS(ON) multi-selective inhibitor taken as a tablet.[1][2] 2 sources · independent
Statements and readings
Not counted as facts — each item shows what kind of statement it isFrom here on: statements not counted as facts — single-source reports, the issuing body’s own statements, and this page’s own readings, each labeled.
The pivotal trial was a randomized, open-label, multicenter study enrolling about 500 adults with previously treated metastatic pancreatic adenocarcinoma.[1] Stated by the issuing body itself (primary source) · not independently verified · 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
- Body characters
- 1,198
- Sources
- 5 sources adopted
- Model
- claude-opus-5 (review pass)
- Time
- 08/27/2026, 02:30
- Verdict
- Passed
Show revision history (4)
| 08/27/2026, 02:30 | First authored (claude-opus-5) | Created |
| 08/27/2026 | First authored | Updated |
| 10/08/2026 | Added sources to one FAQ and corrected it against the FDA announcement. | Updated |
| 10/08/2026 | Aligned the title, a section heading, a paragraph and a fact with the FDA announcement. | Updated |
Corrections
| 10/08/2026 | FAQ correction: replaced "the first approved medicine that directly targets RAS" with the FDA's own wording (first-in-class targeted therapy that targets multiple forms of RAS), and removed the "undruggable" characterisation, which none of the readable sources uses. | Applied |
| 10/08/2026 | Aligned with the FDA's own wording: the title now says "First-in-Class Targeted Therapy" instead of "First RAS-Targeted Therapy"; the first section's heading no longer calls RAS 'undruggable', and its first paragraph and the second fact and the closing summary no longer say this is the first (approved) RAS-targeted therapy. Both now say the FDA called it a first-in-class targeted therapy that targets multiple forms of RAS. 'Undruggable' appears in none of the readable sources, so the term was removed. | Applied |
Frequently asked
Why is the daraxonrasib approval considered historic?
The FDA announced it as a first-in-class targeted therapy for metastatic pancreatic cancer. Rasonque (daraxonrasib), a once-daily tablet, targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma, a disease with historically limited treatment options. In the pivotal trial it improved overall survival to 13.2 months compared to 6.7 months for standard chemotherapy, in a disease with a 13% five-year survival rate.[1][2]
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