Revolution Medicines Receives FDA Breakthrough Therapy Designation for Daraxonrasib in Advanced Pancreatic Cancer with KRAS G12 Mutations
Tuesday, June 24, 2025
Revolution Medicines, Inc. a late-stage clinical oncology firm focused on targeted therapies for RAS-driven cancers, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its investigational candidate daraxonrasib. This designation applies to the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) carrying KRAS G12 mutations.
The designation follows promising findings from the Phase 1 RMC-6236-001 clinical study, which is evaluating daraxonrasib in individuals with metastatic PDAC who have received prior treatment. Breakthrough Therapy Designation is granted to investigational medicines showing early clinical evidence of significant improvement over existing therapies for serious or life-threatening conditions.
KRAS mutations are found in over 90% of PDAC cases, with approximately 85% involving the KRAS G12 variant. Daraxonrasib is designed as a multi-selective RAS(ON) inhibitor, targeting a key driver of tumour growth in these patients.
The company is currently enrolling participants in RASolute 302, a global Phase 3 registrational study assessing the safety and efficacy of daraxonrasib. This trial includes a core patient group with RAS G12 mutations and an expanded population that also considers RAS mutations at G13, Q61, or those without an identified targetable mutation. The study’s main endpoints are progression-free survival and overall survival in the core population, with key secondary endpoints covering outcomes in the broader group.
Source: globenewswire.com
