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European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process

RVMD
  • The EMA's CHMP has initiated a phased review of daraxonrasib data to accelerate assessment ahead of a full marketing authorization application.
  • Revolution Medicines is nearing completion of a rolling New Drug Application submission to the U.S. FDA under the Commissioner's National Priority Voucher pilot program.
  • The EMA designated daraxonrasib as an orphan medicinal product for pancreatic cancer & recognized it as a high priority under the Cancer Medicines Pathfinder project.
  • Pivotal Phase 3 RASolute 302 trial results demonstrated unprecedented improvements in overall survival & progression-free survival compared to standard chemotherapy in previously treated metastatic PDAC patients.
  • Clinical trial data indicated a manageable safety profile & significantly delayed deterioration in cancer-related pain, global health status, & quality of life for patients treated with daraxonrasib.
  • The FDA previously granted daraxonrasib Breakthrough Therapy & Orphan Drug Designations for previously treated metastatic PDAC harboring G12 mutations.
  • Daraxonrasib is an investigational oral RAS(ON) multi-selective inhibitor designed to target diverse RAS mutations across pancreatic, non-small cell lung, & colorectal cancers.
  • The global Phase 3 registrational program includes the completed RASolute 302 trial & three additional trials in PDAC & metastatic RAS mutant NSCLC.
  • Revolution Medicines is engaging with regulatory authorities globally to prepare for submissions in additional territories beyond the U.S. & Europe.