FDA Approves New Drug Rasonque for Advanced Pancreatic Cancer

The US Food and Drug Administration has approved a new once-daily pill called Rasonque, developed by Revolution Medicines, after a large clinical trial showed it doubled survival rates in patients with advanced pancreatic cancer — one of the deadliest and hardest-to-treat cancers.

The drug is approved for patients with metastatic pancreatic cancer who have already undergone prior treatment or who cannot tolerate combination chemotherapy. It works by blocking several forms of the RAS protein, which fuels tumor growth in many pancreatic cancer cases.

High cost, but assistance offered

In the United States, the drug is priced at $39,800 for a 30-day supply, though the company says it will offer financial assistance to patients. Demand surged after Revolution Medicines announced trial results in April, prompting the FDA to quickly grant compassionate-use access, which allows seriously ill patients to receive experimental treatment before formal approval.

The approval came through the FDA's expedited review pathway, which can shrink review timelines to one or two months instead of the usual 10 to 12. Revolution Medicines CEO Mark Goldsmith said the approval validates more than a decade of research into RAS-driven cancers.

Investor and medical response

The company's stock has climbed 166% this year on expectations that Rasonque could become a major treatment option. Analysts at RBC Capital Markets estimate the drug could eventually generate as much as $11.5 billion in annual global sales.

Physicians have described the approval as a breakthrough. Rachna Shroff of the University of Arizona Cancer Center noted that patients not only lived longer but also experienced improved quality of life. Some patients who received early access have already reported relief from the harsh side effects of chemotherapy.