FDA Approves Pancreatic Cancer Drug That Nearly Doubled Survival In Trial

The U.S. Food and Drug Administration (FDA) on Wednesday approved a groundbreaking new treatment for advanced pancreatic cancer that nearly doubled median survival in a clinical trial, marking what experts are calling one of the biggest advances against the deadly disease in decades.

The drug, daraxonrasib, which will be sold under the brand name Rasonque, is approved for metastatic pancreatic adenocarcinoma, the most common form of pancreatic cancer. Developed by Revolution Medicines, Rasonque is a once-daily pill designed to block RAS proteins that play a key role in driving tumor growth.

The FDA approved Rasonque for adults with metastatic pancreatic cancer who have already received at least one cancer treatment, such as chemotherapy, or who cannot undergo combination treatment. The approval came approximately 6.5 months ahead of the FDA’s goal date, following an expedited review.

“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,” acting FDA Commissioner Kyle Diamantas said in a press release. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”

The decision was based on results from a trial that included 500 patients whose metastatic pancreatic cancer had progressed after previous treatment. Patients who received daraxonrasib had a median overall survival of 13.2 months, compared with 6.7 months for those who received standard chemotherapy.

The drug also significantly delayed disease progression. Patients taking Rasonque went about twice as long without their cancer getting worse compared with those receiving standard chemotherapy. The risk of death was reduced by 60% in the trial.

“It will be transformative in the way we treat pancreas cancer. It’s the biggest development we’ve had in pancreas cancer in decades,” Andrew Ko, a gastrointestinal cancer specialist at the University of California, told STAT. “I’m so thankful for this as an advance for our patients.”

Rachna Shroff, a pancreatic cancer specialist at the University of Arizona Cancer Center, described an emotional reaction to the trial results earlier this year.

“Having treated pancreatic cancer for 16 years, I actually started crying in the clinic,” Shroff said, according to STAT. “This is such an incredibly impactful study for our patients.”

The National Cancer Institute estimates that 67,530 Americans will be diagnosed with pancreatic cancer in 2026, while 52,740 are expected to die from the disease. The overall five-year relative survival rate is just 13.3%.

The FDA said the most common side effects associated with Rasonque include rash, diarrhea, inflammation of the mouth, nausea, fatigue, vomiting, abdominal pain, swelling, decreased appetite, and hemorrhage.

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