EMA Starts Phased Review of Daraxonrasib After Phase 3 Survival Gains
RVMD•EMA’s Committee for Medicinal Products for Human Use has commenced a phased review of daraxonrasib for pancreatic cancer following pivotal Phase 3 RASolute 302 data showing unprecedented overall and progression-free survival gains. The rolling NDA submission to the US FDA under the National Priority Voucher pilot program is nearing completion.
1. EMA Phased Review Initiation
The EMA’s Committee for Medicinal Products for Human Use has begun a phased assessment of daraxonrasib, Revolution Medicines’ investigational RAS(ON) multi-selective inhibitor in pancreatic cancer. This process allows the agency to evaluate clinical data in stages ahead of a full marketing authorization application, expediting potential approval.
2. FDA NDA Rolling Submission Progress
Revolution Medicines is nearing completion of its rolling New Drug Application to the US FDA under the Commissioner’s National Priority Voucher pilot program, which accelerates review of treatments aligned with national health priorities. Engagement with FDA reviewers has been strong, positioning the company for a timely submission finish.
3. Phase 3 Trial Results
The pivotal RASolute 302 trial demonstrated unprecedented improvements in overall survival and progression-free survival versus standard cytotoxic chemotherapy in metastatic pancreatic ductal adenocarcinoma. Daraxonrasib also showed a manageable safety profile and significantly delayed deterioration in patient-reported pain and quality of life metrics.
