FDA Approves Rasonque for Metastatic PDAC; Price Concerns

The FDA approved Revolution Medicines’ Rasonque (daraxonrasib), a first-in-class RAS-selective inhibitor, for adults with metastatic pancreatic ductal adenocarcinoma who have received prior therapy or cannot undergo multiagent chemotherapy. In the pivotal Phase 3 RASolute 302 trial, Rasonque produced a median overall survival of 13.2 months, compared with 6.7 months for standard chemotherapy, a roughly 60% reduction in the risk of death. The trial also showed a median progression-free survival of about 7.2 months versus 3.6 months. The daily pill is priced at roughly $39,800 per month, raising questions about cost and access in the United States and abroad, even as doctors and patient advocates applauded the breakthrough and urged rapid availability in other markets such as the United Kingdom. Revolution Medicines’ stock and price targets rose following the news, signaling positive investor sentiment about the potential to redefine care for this hard-to-treat cancer. Experts say the approval could influence development of similar approaches for other cancers and represents a significant advance in treating pancreatic cancer.