EMA Accelerates Review of Revolution Medicines' Pancreatic Cancer Drug
The European Medicines Agency (EMA) has commenced a phased review of Revolution Medicines' experimental drug daraxonrasib, intended for the treatment of metastatic pancreatic cancer. This approach allows the EMA to assess data as it becomes available, potentially shortening the overall review timeline while ensuring thorough evaluation.
The decision follows promising results from the Phase 3 RASolute trial, which compared daraxonrasib to standard chemotherapy in patients with previously treated metastatic pancreatic ductal carcinoma. This form of cancer typically offers a median life expectancy of about six months, underscoring the urgent need for new therapies.
Daraxonrasib has been granted several expedited designations, including Breakthrough Therapy and Orphan Drug status by the U.S. Food and Drug Administration (FDA), and a high-priority designation under the EMA's Cancer Medicines Pathfinder program. These designations reflect the drug's potential to address significant unmet medical needs.
In parallel, Revolution Medicines has initiated a rolling submission to the FDA's National Priority Review Program, indicating a similar accelerated review process in the United States.