In brief
In a landmark decision, the FDA approved daraxonrasib (Rasonque) after a Phase III study showed median survival doubled from 6.6 to 13.2 months. The drug targets the KRAS gene mutation found in most pancreatic tumours, potentially curbing cancer spread. With 67,000 new U.S. cases annually and a fatality rate exceeding 50 % within three months, this breakthrough offers a critical new option. While side‑effect rates are lower than chemotherapy, rare severe reactions still occur. Former U.S. Senator Ben Sasse reports tumours shrinking after enrolling in a trial.
US regulators approved on Aug. 26, 2026 a new oral therapy—daraxonrasib, marketed as Rasonque—after a Phase III study showed it almost doubled overall survival for pancreatic cancer patients.
In a trial that enrolled 500 people, the daily dose extended median survival from 6.6 months for standard chemotherapy to 13.2 months for patients taking the drug.
Daraxonrasib works by blocking the mutated KRAS gene, a driver in over 90 % of pancreatic tumours, thereby hampering the cancer’s ability to spread.
Pancreatic cancer continues to be the deadliest of all major cancers in the U.S., with roughly 67,000 new cases announced each year and a 3‑month mortality rate exceeding 50 %.
The FDA granted the drug a “Breakthrough Therapy” designation in 2025 and approved it six months ahead of the usual deadline, citing the drug’s “unprecedented results” in a high‑need area.
Reported side effects include rash, diarrhoea, nausea, fatigue and vomiting; about 44 % of patients on daraxonrasib experienced severe side effects, compared with 57.5 % on chemotherapy.
Former Senator Ben Sasse, who disclosed a Stage‑4 diagnosis in December, is currently enrolling in a clinical trial for the drug and says it has helped shrink his tumours.
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