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

• Phased review by EMA aims to accelerate assessment of company's investigational drug daraxonrasib in pancreatic cancer based on unprecedented clinical results from pivotal Phase 3 RASolute 302 trial
  

• Rolling submission of NDA for daraxonrasib to U.S. FDA under Commissioner's National Priority Voucher pilot program nearing completion
  

REDWOOD CITY, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a phased review of data on daraxonrasib, the company's investigational RAS(ON) multi-selective inhibitor. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases as they become available, ahead of the submission of a full marketing authorization application. Daraxonrasib was designated by the EMA as an orphan medicinal product for the treatment of pancreatic cancer and has been recognized as a high priority under EMA's Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need.

In addition, the company continues to make significant progress on its rolling submission of a New Drug Application (NDA) for daraxonrasib to the U.S. Food and Drug Administration (FDA) under the Commissioner's National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.

"As our rolling submission of an NDA to the FDA nears completion, we are encouraged by the strong engagement we've received from health authorities around the world," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "The EMA's decision to include daraxonrasib in its new phased review process is an important step toward making this medicine available to patients globally as quickly as possible. We believe this milestone underscores both the significant unmet medical need in pancreatic cancer and the potential of daraxonrasib to address that need."

The company continues to engage in discussions with regulatory authorities around the world as it prepares for submissions in additional territories. The ongoing FDA review and planned regulatory submissions in other territories are supported by the positive results from the pivotal Phase 3 RASolute 302 trial, which demonstrated unprecedented improvements in overall survival and progression-free survival compared to standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. In the trial, daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy.