REDWOOD CITY, Calif., July 7, 2026
Revolution Medicines has announced a major regulatory milestone as the European Medicines Agency (EMA) initiated a phased review of its investigational RAS(ON) multi-selective inhibitor daraxonrasib for the treatment of pancreatic ductal adenocarcinoma (PDAC). The accelerated assessment follows the unprecedented positive results from the pivotal Phase 3 RASolute 302 trial, which demonstrated significant improvements in overall survival and progression-free survival compared with standard chemotherapy in patients with previously treated metastatic pancreatic cancer. At the same time, the company confirmed that its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) under the Commissioner’s National Priority Voucher pilot program is nearing completion. The dual regulatory progress underscores growing global recognition of daraxonrasib’s potential to address one of the most challenging cancers with significant unmet medical need while accelerating patient access to an innovative targeted therapy.
EMA Phased Review Accelerates Regulatory Pathway for Daraxonrasib
The EMA Committee for Medicinal Products for Human Use (CHMP) has begun evaluating daraxonrasib through its phased review process, an accelerated regulatory mechanism that allows clinical, non-clinical, and manufacturing data to be assessed as they become available before submission of the complete Marketing Authorization Application (MAA). Daraxonrasib has also received Orphan Medicinal Product Designation from the EMA and has been recognized under the agency’s Cancer Medicines Pathfinder initiative, reflecting its potential to address the urgent treatment needs of patients with advanced pancreatic cancer. Simultaneously, Revolution Medicines is progressing toward completion of its rolling NDA submission to the FDA, utilizing the National Priority Voucher pilot program, which is designed to expedite review of therapies addressing critical public health priorities. Together, these regulatory initiatives have the potential to shorten review timelines and support earlier availability of the investigational therapy across multiple global markets if approved.
Phase 3 Results Strengthen Promise of Novel RAS(ON) Targeted Therapy
Daraxonrasib is an investigational oral RAS(ON) multi-selective, non-covalent tri-complex inhibitor developed to target a broad spectrum of RAS-driven cancers, including pancreatic cancer, non-small cell lung cancer (NSCLC), and colorectal cancer. The positive regulatory momentum is supported by results from the pivotal Phase 3 RASolute 302 clinical trial, which demonstrated unprecedented improvements in overall survival and progression-free survival compared with cytotoxic chemotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma, regardless of whether tumors carried identified RAS mutations. Patients receiving daraxonrasib also experienced delayed deterioration in cancer-related pain, overall health status, and quality of life while maintaining a manageable safety profile, highlighting both clinical efficacy and patient-centered benefits.
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The investigational therapy is currently being evaluated through a comprehensive global Phase 3 registration program that includes additional studies in pancreatic cancer and RAS-mutant non-small cell lung cancer. With more than 90% of pancreatic ductal adenocarcinomas driven by RAS mutations and long-term survival remaining extremely poor, daraxonrasib represents one of the most promising next-generation targeted therapies currently advancing through late-stage clinical development. If approved, the therapy could significantly expand treatment options for patients facing one of the deadliest forms of cancer while reinforcing Revolution Medicines’ leadership in precision oncology and RAS-targeted drug development.
Source: Revolution Medicines press release
