The U.S. Food and Drug Administration has approved a landmark drug to treat advanced pancreatic cancer, a development expected to significantly improve patient survival.
The drug, Rasonque (daraxonrasib), developed by Revolution Medicines, is a once-daily oral tablet that targets multiple forms of the RAS protein — a key driver of tumor growth in most patients with pancreatic adenocarcinoma, a cancer that originates in the cells lining the pancreatic ducts, the FDA said in a news release on Wednesday, August 26.
“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.
Data from the National Cancer Institute show that about 90% to 95% of the 67,000 pancreatic cancer cases diagnosed annually in the United States are pancreatic adenocarcinoma.
“Despite representing roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths, owing to its typically late detection, aggressive disease course, and historically limited treatment options,” the FDA said.
The drug was approved following a successful clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma.
“Rasonque improved median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy,” the FDA said.
The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations. It also received priority review and was evaluated under the Commissioner’s National Priority Voucher pilot program, which aims to accelerate therapies addressing key public health needs.
The FDA said the drug’s most common side effects include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. — Photo from Revolution Medicines
