FDA Approves Daraxonrasib, First RAS-Targeting Pancreatic Cancer Drug

The U.S. Food and Drug Administration (FDA) on Wednesday granted expedited approval to daraxonrasib (brand name Rasonque), a first-in-class pill for adults with metastatic pancreatic cancer who have received prior treatment or cannot undergo combination chemotherapy. The drug, developed by Revolution Medicines, targets mutations in the RAS gene family that fuel tumor growth in more than 90% of pancreatic cancer cases, an approach long considered "undruggable." Source: AP News

Clinical impact

In a company-funded trial of 500 patients with previously treated metastatic pancreatic ductal adenocarcinoma, daraxonrasib nearly doubled median overall survival to 13.2 months versus 6.7 months for chemotherapy, and reduced the risk of death by 60%. Source: Gizmodo The drug also extended progression-free survival to 7.2 months versus 3.6 months. Source: Gizmodo Common side effects included rash, diarrhea, mouth sores, and fatigue. Source: NPR

Pricing and access

Revolution Medicines set a list price of $39,800 for a 30-day supply, with co-pay assistance potentially reducing out-of-pocket costs to $0 for eligible commercially insured patients. Source: CNN The FDA approved the drug more than six months ahead of its target date, partly due to its inclusion in the FDA Commissioner's National Priority Voucher program, which accelerates reviews for therapies addressing major health priorities. Source: CNN

Reaction and outlook

Doctors and patient advocates welcomed the approval as a significant advance for a cancer with a five-year survival rate of only 13%. Source: AP News "This is one of the most anticipated approvals I can think of," said Dr. Andrew Coveler of Fred Hutch Cancer Center. Source: NPR The drug's early access program, which enrolled more than 2,000 patients, drew public attention after former Sen. Ben Sasse described his positive experience on "60 Minutes." Source: NPR Analysts project the drug could generate $11.5 billion in annual sales, and researchers hope it will pave the way for similar RAS-targeting therapies in other cancers. Source: CNN