FDA Approves Promising New Treatment for Advanced Pancreatic Cancer
Patients with advanced pancreatic cancer gained an encouraging new treatment option Wednesday as the U.S. Food and Drug Administration approved Rasonque, a once-daily pill that produced significant survival benefits in a clinical trial.
Rasonque, also known as daraxonrasib, is intended for adults with metastatic pancreatic adenocarcinoma, the most common type of pancreatic cancer. The approval covers patients who have received at least one previous cancer therapy, including chemotherapy, as well as those unable to undergo combination treatment.
Developed by Revolution Medicines, the drug works by blocking RAS proteins, which help fuel tumor growth. The FDA completed its expedited review approximately six and a half months ahead of its target date.
“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 agency’s decision was supported by a clinical trial involving 500 people whose metastatic pancreatic cancer had continued progressing after earlier treatment. Participants who received daraxonrasib had a median overall survival of 13.2 months, compared with 6.7 months among those treated with standard chemotherapy.
Rasonque also helped patients go approximately twice as long without their cancer worsening. Trial results showed that the treatment reduced the risk of death by 60%.
Cancer specialists welcomed the findings as a major step forward for patients and their families.
“It will be transformative in the way we treat pancreas cancer. It’s the biggest development we’ve had in pancreas cancer in decades,” University of California gastrointestinal cancer specialist Andrew Ko 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, shared how deeply the positive trial results affected her.
“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 approval offers renewed hope in the fight against a disease that remains especially challenging. The National Cancer Institute estimates that 67,530 Americans will be diagnosed with pancreatic cancer in 2026 and that 52,740 people will die from it. The overall five-year relative survival rate is 13.3%.
According to the FDA, the most frequently reported side effects of Rasonque include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, swelling, reduced appetite, and hemorrhage.
