Uploaded August 2026 | Updated September 2026, 2 weeks ago
U.S. health regulators approved a once-daily pill for adults with advanced pancreatic cancer, offering a new option for patients, the Food and Drug Administration (FDA) announced.
The FDA on Wednesday said it approved the drug, Rasonque, known generically as daraxonrasib, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic treatment or cannot receive multiagent systemic therapy.
"Today's approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer," Acting FDA Commissioner Kyle Diamantas, J.D. said in a news release.
"It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible," she added. "I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality."
Rasonque, which is made by Revolution Medicines Inc., targets multiple forms of RAS, a protein that drives tumor growth in most pancreatic adenocarcinomas. The cancer begins in cells lining the pancreatic ducts and is often difficult to detect until it has spread.
The approval followed a randomized clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, according to the release. Patients who received daraxonrasib had a median overall survival of 13.2 months, compared with 6.7 months for patients receiving standard chemotherapy, the FDA said.
"This drug showed unprecedented results in an area of high unmet need," Angelo de Claro, M.D., who is the director of the FDA's Oncology Center of Excellence, said. "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."
In May, the FDA allowed Revolution Medicines to begin an expanded-access protocol, enabling eligible patients to receive the investigational drug before its approval.
Common side effects of the medication include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, swelling, reduced appetite, and hemorrhage, per the FDA.
Citing the National Cancer Institute, the FDA said pancreatic adenocarcinoma accounts for an estimated 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the U.S. each year.
U.S. health regulators approved a once-daily pill for adults with advanced pancreatic cancer, offering a new option for patients, the Food and Drug Administration (FDA) announced.
The FDA on Wednesday said it approved the drug, Rasonque, known generically as daraxonrasib, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic treatment or cannot receive multiagent systemic therapy.
"Today's approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer," Acting FDA Commissioner Kyle Diamantas, J.D. said in a news release.
"It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible," she added. "I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality."
Rasonque, which is made by Revolution Medicines Inc., targets multiple forms of RAS, a protein that drives tumor growth in most pancreatic adenocarcinomas. The cancer begins in cells lining the pancreatic ducts and is often difficult to detect until it has spread.
The approval followed a randomized clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, according to the release. Patients who received daraxonrasib had a median overall survival of 13.2 months, compared with 6.7 months for patients receiving standard chemotherapy, the FDA said.
"This drug showed unprecedented results in an area of high unmet need," Angelo de Claro, M.D., who is the director of the FDA's Oncology Center of Excellence, said. "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."
In May, the FDA allowed Revolution Medicines to begin an expanded-access protocol, enabling eligible patients to receive the investigational drug before its approval.
Common side effects of the medication include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, swelling, reduced appetite, and hemorrhage, per the FDA.
Citing the National Cancer Institute, the FDA said pancreatic adenocarcinoma accounts for an estimated 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the U.S. each year.
