WASHINGTON (WDNews) — The U.S. Food and Drug Administration has approved a first-of-its-kind targeted therapy for the most common form of pancreatic cancer, offering a new treatment option for some patients with advanced disease.
The FDA announced Wednesday, Aug. 26, the approval of Rasonque, also known as daraxonrasib. The once-daily tablet targets multiple forms of a protein known as RAS, which plays a key role in tumor growth in most patients with pancreatic adenocarcinoma.
The treatment is approved for adults with metastatic pancreatic adenocarcinoma who have already received at least one systemic therapy or who are not candidates for multiagent systemic therapy.
“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, J.D., said.
The FDA said about 90% to 95% of the roughly 67,000 new pancreatic cancer cases diagnosed in the United States each year are pancreatic adenocarcinoma.
The new treatment showed significant results during a clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma.
According to the FDA, patients receiving Rasonque had a median overall survival of 13.2 months, compared with 6.7 months for patients receiving standard chemotherapy.
“This drug showed unprecedented results in an area of high unmet need,” Dr. Angelo de Claro, 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.”
Rasonque received Breakthrough Therapy and Orphan Drug designations as well as Priority Review. The FDA said the application was also reviewed through the Commissioner’s National Priority Voucher pilot program.
The most commonly reported side effects include rash, diarrhea, inflammation of the mouth, nausea, fatigue, vomiting, abdominal pain, swelling, decreased appetite and hemorrhage.
The FDA granted the approval to Revolution Medicines.
More information about the approval is available through the FDA’s official announcement.
