Revolution Medicines’ Daraxonrasib Receives U.S. FDA Orphan Drug Designation for Pancreatic Cancer
Tuesday, October 28, 2025
Revolution Medicines, Inc. a late-stage clinical oncology company focused on developing targeted therapies for RAS-driven cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to daraxonrasib, its RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer.
Daraxonrasib is currently being evaluated in a global Phase 3 clinical trial, RASolute 302, for patients with second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The company also plans to begin two additional Phase 3 studies—one investigating daraxonrasib as a first-line treatment for metastatic PDAC, and another assessing its potential as an adjuvant therapy for patients with resectable PDAC.
The FDA awards Orphan Drug Designation to investigational therapies aimed at treating rare diseases, defined as conditions affecting fewer than 200,000 individuals in the United States. This designation provides several benefits to sponsors, including tax credits for clinical trial costs, exemption from certain regulatory fees, and up to seven years of market exclusivity after approval.
Pancreatic cancer remains one of the most aggressive and lethal cancers, often diagnosed at a late stage and resistant to conventional chemotherapy. In the United States, it is estimated that around 60,000 people are diagnosed with pancreatic cancer each year, with approximately 50,000 deaths attributed to the disease.
Due to the absence of early symptoms and reliable detection methods, nearly 80% of pancreatic cancer cases are identified at an advanced or metastatic stage. More than 90% of PDAC tumours contain RAS mutations, making it one of the most RAS-dependent cancer types. Metastatic PDAC continues to be a leading cause of cancer-related deaths in the U.S., with a five-year survival rate of about 3%.
Source: globenewswire.com
