Revolution Medicines, Inc. (RVMD), a late-stage clinical oncology company, announced Monday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daraxonrasib, the company's RAS(ON) multi-selective inhibitor, for previously treated metastatic 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 evaluating daraxonrasib in patients with previously treated metastatic PDAC.
Revolution Medicines is currently enrolling patients in RASolute 302, a global Phase 3 registrational study of daraxonrasib in patients with previously treated metastatic PDAC.
The dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS and OS in the expanded population of patients.
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations.
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