On 26 August 2026 the U.S. Food and Drug Administration approved RASONQUE (daraxonrasib), a once-daily tablet from Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma who have already had at least one systemic therapy — or who cannot take multi-agent chemotherapy. That is the label, filed the same day in an 8-K. It is not a cure. It is not first-line treatment for everyone with pancreatic cancer. Once-daily tablets are available in the United States now. The wholesale acquisition cost is $39,800 for a 30-day supply.
The survival numbers under that approval are not new this week. They were presented at the 2026 American Society of Clinical Oncology Annual Meeting and published at the same time in The New England Journal of Medicine. What changed on 26 August is the license, a U.S. pharmacy channel, and a list price.
In the intent-to-treat population of RASolute 302, RASONQUE cut the risk of death by 60 percent versus investigator’s-choice chemotherapy: hazard ratio 0.40 (95% CI 0.30–0.53; p<0.0001). Median overall survival was 13.2 months (10.0–NE) against 6.7 months (5.8–8.0). Median progression-free survival was 7.2 months against 3.6 months. Rash is common: dermatologic toxicity showed up in 86 percent of patients in the pancreatic-adenocarcinoma trials, Grade 3 in 10 percent.
Why it matters
Metastatic pancreatic adenocarcinoma is a cancer where “new drug” headlines usually fail to move survival. Revolution Medicines, citing Oracle CancerMPact and American Cancer Society figures, puts U.S. PDAC diagnoses at about 55,000 a year and says more than 50,000 people die of the disease under current care. About 80 percent of patients are diagnosed after the cancer has already spread. For metastatic PDAC, five-year relative survival is about 3 percent.
The Pancreatic Cancer Action Network calls the Phase 3 result a doubling of survival versus chemotherapy in previously treated metastatic disease. The months are 13.2 versus 6.7. That is not “doubled survival for all pancreatic cancer.” Median survival is still measured in months: half the people on the pill arm were not alive at 13.2 months. PanCAN’s separate all-stages five-year figure of 13 percent is a different statistic. Do not mix them.
RAS is the growth switch that drives most of this disease. PanCAN says RAS mutations, especially in KRAS, are found in more than 90 percent of pancreatic cancers. For decades the proteins were treated as undruggable. RASONQUE is an oral RAS(ON) multi-selective inhibitor, designed to block the active form of both wild-type and mutant RAS. The approved use does not require a companion diagnostic: adults with or without an identified RAS tumor mutation can be prescribed it.
A different 2026 cancer story is still waiting on a label. Merck and Moderna’s personalized mRNA melanoma vaccine cleared a Phase 3 recurrence-free-survival bar this month; it is not approved. RASONQUE is.
The print
Revolution Medicines’ 26 August release, matching the 8-K, is the source for the table. ITT means everyone randomized, including people without an identified RAS mutation.
| RASONQUE | Chemotherapy | |
|---|---|---|
| Median overall survival (ITT) | 13.2 months (10.0–NE) | 6.7 months (5.8–8.0) |
| Death-risk HR (ITT) | 0.40 (0.30–0.53; p<0.0001) | — |
| Median PFS (ITT) | 7.2 months (5.7–7.5) | 3.6 months (2.9–4.2) |
| PFS HR (ITT) | 0.49 (0.38–0.64; p<0.0001) | — |
| U.S. PDAC diagnoses / year | ~55,000 | |
| Metastatic 5-year relative survival | ~3% | |
| WAC, 30-day supply | $39,800 |
Quality-of-life scores moved in the same direction. Time to deterioration in global health status was 5.7 months versus 2.6 months; in clinically relevant pain, 9.2 months versus 3.8 months. Those are patient-reported delays, not a claim that the disease stopped hurting.
The safety file
Do not bury this. The U.S. label, as quoted in the company release, warns for dermatologic toxicity, stomatitis, diarrhea, gastrointestinal perforation, interstitial lung disease / pneumonitis, and embryo-fetal toxicity.
In pancreatic-adenocarcinoma trials:
- Dermatologic toxicity: 86%, including 10% Grade 3. Rash, itch, paronychia, dry skin, fissures. The label tells clinicians to start prophylaxis — topical corticosteroids, emollients, sunscreen, consider oral antibiotics — before the first dose, and to tell patients to limit sun.
- Diarrhea: 63%, 6% Grade 3.
- Stomatitis (mouth sores): 57%, 9% Grade 3.
- Gastrointestinal perforation: 0.9%. One event was Grade 4. One was fatal.
- ILD / pneumonitis: 2.4%, 0.9% Grade 3. One event was fatal.
Serious adverse reactions occurred in 30 percent of patients. Permanent discontinuation happened in 2.9 percent. The most common reactions at 20 percent or more were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. It is not a gentle pill. The two fatal rare events are why the label tells doctors to stop the drug if perforation or pneumonitis is suspected.
How they did it
The approval rests on RASolute 302 (NCT06625320), a global, randomized, open-label Phase 3 trial of RASONQUE versus investigator’s choice of cytotoxic chemotherapy in previously treated metastatic PDAC. ClinicalTrials.gov lists 500 patients enrolled. The experimental arm took 300 mg orally once a day. The control arm was one of four standard regimens: gemcitabine plus nab-paclitaxel; modified FOLFIRINOX; liposomal irinotecan with 5-FU/leucovorin; or FOLFOX.
Primary endpoints were progression-free survival, read by blinded independent central review under RECIST 1.1, and overall survival in the RAS G12-mutant subgroup. Secondary endpoints included PFS and OS in the full intent-to-treat population. The company says the trial met all primary and key secondary endpoints in both groups, and that G12 results were generally consistent with ITT. We are printing the ITT numbers because that is the population the 26 August release led with.
The principal investigator is Brian M. Wolpin of Dana-Farber and Harvard Medical School. Revolution Medicines is based in Redwood City, California. CEO Mark A. Goldsmith called it the first targeted medicine designed to inhibit RAS, “the main cause of pancreatic cancer.”
The price, and who can get it
The 8-K is blunt on cost: wholesale acquisition cost $39,800 for a 30-day supply at the recommended daily dose. That is the list price to wholesalers, not what any one patient will pay. FDA approval does not set coverage. Revolution Medicines launched (ON)Path for insurance navigation and financial assistance. PanCAN says people already on expanded access will move onto commercial supply. We are not printing a U.S. patient count already treated; the company did not put one in the 8-K or the approval release.
Outside the United States, daraxonrasib is still investigational. The European Medicines Agency has started a phased review. The FDA had already given Breakthrough Therapy and Orphan Drug designations for previously treated metastatic PDAC.
What this is not
- Not a cure. Median overall survival on the pill was 13.2 months.
- Not first-line for everyone. The indication is metastatic PDAC after at least one systemic therapy, or in people who cannot take multi-agent chemo.
- Not “doubled survival for all pancreatic cancer.” PanCAN’s doubling language is about this previously treated metastatic trial: 13.2 months versus 6.7. Keep the months.
- Not a claim that RAS testing is required. The label does not need a companion diagnostic. PanCAN still recommends biomarker testing, because people without a KRAS mutation may have a different target.
What to watch
- Who actually gets the pill at $39,800 a month. WAC is not reimbursement. Payer policies and (ON)Path uptake will decide whether the label is a clinic option or a press release.
- First-line and adjuvant use. PanCAN notes ongoing trials of RASONQUE with chemotherapy and after surgery. Those are not this approval.
- Europe. EMA’s phased review is the next regulator with a clock.
- Resistance. PanCAN is explicit that not every tumor will respond and that some that do will stop. Combination studies are the test of whether 13.2 months is a ceiling.
- Other RAS tumors. The FDA has a Breakthrough Therapy designation for previously treated metastatic NSCLC with KRAS mutations other than G12C. That is a designation, not a second label.
Sources
- Revolution Medicines, Form 8-K, 26 August 2026 — https://www.sec.gov/Archives/edgar/data/1628171/000119312526366931/rvmd-20260826.htm
- Revolution Medicines, “U.S. FDA Approves Revolution Medicines’ RASONQUE (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer,” 26 August 2026 — https://ir.revmed.com/news-releases/news-release-details/us-fda-approves-revolution-medicines-rasonquetm-daraxonrasib
- Pancreatic Cancer Action Network, “FDA Approves RASONQUE (daraxonrasib)” — https://pancan.org/news/fda-approves-rasonque-daraxonrasib/
- ClinicalTrials.gov, RASolute 302, NCT06625320 — https://clinicaltrials.gov/study/NCT06625320
