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FDA Approves Daraxonrasib for Metastatic Pancreatic Cancer Following Landmark Clinical Trial Led by Dana-Farber

The U.S. Food and Drug Administration (FDA) has approved daraxonrasib, an oral multi-selective RAS(ON) inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The approval is based primarily on the results from the pivotal randomized phase 3 RASolute 302 trial comparing daraxonrasib to chemotherapy as second-line therapy for patients with metastatic pancreatic cancer, led by Brian Wolpin, MD, MPH, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute.

August 26, 2026


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