FDA Greenlights Daraxonrasib: A Landmark Breakthrough in Pancreatic Cancer Treatment

After decades of limited progress, a new drug has dramatically extended survival for patients with metastatic pancreatic cancer—marking a pivotal shift in the battle against this deadly disease.

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A Long‑Awaited Approval

On August 26, 2026, the U.S. Food and Drug Administration granted accelerated approval to daraxonrasib—marketed as Rasonque—for adults with metastatic pancreatic adenocarcinoma who have previously undergone at least one systemic therapy or are ineligible for multiagent treatment . This marks the first approval of a RAS‑targeted therapy for the most common form of pancreatic cancer, a milestone in a landscape where effective options have been scarce .

Clinical Trial Results That Changed the Game

The approval rests on the phase 3 RASolute 302 trial, which randomized 500 patients across six countries to receive either daraxonrasib or physician‑chosen chemotherapy . The results were striking: median overall survival soared to 13.2 months in the daraxonrasib arm versus just 6.7 months with chemotherapy—a 60% reduction in the risk of death (HR 0.40; p < 0.0001) . Progression‑free survival also doubled—from 3.6 to 7.2 months (HR 0.49; p < 0.0001) .