FDA approves a first-of-its-kind pill that nearly doubled median survival in an advanced pancreatic cancer trial
Aug. 26, 2026 — The FDA has approved Rasonque (daraxonrasib), a daily pill from Redwood City, Calif.-based Revolution Medicines, for adults whose pancreatic adenocarcinoma has spread and has already been treated, or who cannot take combination chemotherapy. The company says it is the first approved drug that targets multiple forms of RAS, a protein that drives tumor growth in most cases of the disease and that eluded drug developers for decades.
In a randomized trial of 500 previously treated patients, those taking Rasonque lived a median 13.2 months, compared with 6.7 months on chemotherapy, a 60% reduction in the risk of death. Patients on the drug also went longer before their cancer worsened, a median 7.2 months versus 3.6. The trial was open-label and funded by the company. No genetic test is required. Common side effects included rash, diarrhea, mouth sores and nausea, and the label warns of risks including gastrointestinal perforation and lung inflammation.
Pancreatic cancer accounts for about 3% of U.S. cancers but 8% of cancer deaths, and the American Cancer Society expects about 67,530 new diagnoses this year. About half of pancreatic cancers become metastatic.
The FDA approved the drug about 6.5 months ahead of its review deadline, under a pilot program of priority vouchers, after allowing expanded access in May. Cancer centers had prepared for a surge in demand months before approval, Becker's Hospital Review reported. The company set a list price of $39,800 for a 30-day supply.
The wall: Overall survival data are from a company-funded, open-label trial; long-term results and insurance coverage are not yet known.
Tier: Confirmed (key facts read in primary at passage level or better)
Sources
- FDA approval notice
- Revolution Medicines Form 8-K (price)
- American Cancer Society key statistics
- Consultant360 (side effects, review timing)
- AP via Michigan Public
- Becker's Hospital Review (demand)
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