US regulator clears once-daily pill for late-stage pancreatic cancer
The US Food and Drug Administration has approved a new oral medication for patients with advanced pancreatic cancer. Developed by Revolution Medicines, the drug was shown in a major trial to double survival rates for those with metastatic disease. It is now available at a list price of $39,800 per month, with patient assistance programs offered.
The approval came through the FDA's expedited review pathway, compressing the standard 10-to-12-month evaluation window to roughly one to two months. More than 2,000 patients had already received the medication through the agency's compassionate use program before commercial availability began, reflecting strong early demand.
Analysts project third-quarter US revenue of approximately $28 million from the drug, climbing to $148 million in the fourth quarter, with potential long-term annual global sales of $11.5 billion. The American Cancer Society estimates about 67,350 new pancreatic cancer diagnoses in the US this year, underscoring the patient population the treatment could serve.
The approval could meaningfully change the outlook for patients with advanced pancreatic cancer, a disease with historically grim survival prospects. While the $39,