(NewsNation) — A groundbreaking new drug for advanced pancreatic cancer was approved by the U.S. Food and Drug Administration Wednesday.
Agency officials announced it gave the pill, daraxonrasib, approval more than six months ahead of a target date. The drug blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases.
"Today's approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible," said acting FDA Commissioner Kyle Diamantas. "I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality."
Studies of the landmark medication showed patients nearly doubled their survival rate and had fewer dangerous side effects. Those participants lived for over 13 months compared with nearly seven months for chemotherapy recipients.
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"This drug showed unprecedented results in an area of high unmet need," added Angelo de Claro, director of the FDA's Oncology Center of Excellence. "The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA's commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions."
The drugs will be sold under the brand name Rasonque by Revolution Medicines.
The American Cancer Society estimates about 67,000 new cases of pancreatic cancer will be diagnosed in the United States in 2026, while just under 52,000 people will die from the disease.
The five-year overall survival rate for pancreatic cancer patients is 13%, the ACA notes.
The Associated Press contributed to this report.
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