Revolution Medicines, Inc. announced on June 23, 2025, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daraxonrasib, its RAS(ON) multi-selective inhibitor. This designation is for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) in patients with KRAS G12 mutations.
The Breakthrough Therapy Designation is based on encouraging data from the Phase 1 RMC-6236-001 clinical trial, which evaluated daraxonrasib in patients with previously treated metastatic PDAC. This designation is intended to expedite the development and review of potential new medicines for serious conditions with unmet medical needs, where preliminary clinical evidence shows substantial improvement over existing treatments.
This milestone highlights the significant need for new treatments for pancreatic cancer, where over 90% of patients have RAS mutations and approximately 85% carry a KRAS G12 mutation. Revolution Medicines is actively enrolling patients in the global Phase 3 RASolute 302 study for daraxonrasib in this indication, with substantial enrollment expected to complete in 2025 for a 2026 data readout.
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