FDA Approves Oral Drug That Doubles Pancreatic Cancer Survival

The U.S. Food and Drug Administration on Wednesday approved Rasonque, a first-of-its-kind oral medication for advanced pancreatic cancer, marking a significant breakthrough in treating one of the deadliest forms of the disease. The once-daily pill, developed by Revolution Medicines and known generically as daraxonrasib, is designed to block multiple forms of the RAS protein, a mutation that drives tumor growth in more than 90% of pancreatic cancers.

The approval was based on results from a Phase 3 clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma. Patients who received Rasonque lived for a median of 13.2 months, nearly doubling the 6.7-month median survival observed in those treated with standard chemotherapy. The drug reduced the risk of death by 60% and also delayed disease progression. "This drug showed unprecedented results in an area of high unmet need," said Angelo de Claro, director of the FDA's Oncology Center of Excellence.

Rasonque is approved for adults with metastatic pancreatic cancer whose disease has progressed after prior treatment or who are not candidates for standard combination chemotherapy. Notably, the...