The U.S. Food and Drug Administration recently approved Rasonque (daraxonrasib), a once-daily RAS inhibitor for metastatic pancreatic adenocarcinoma, giving patients with advanced pancreatic cancer a new targeted treatment option months ahead of schedule.

The approval applies to adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy, a news release from the agency said.

Rasonque targets multiple forms of RAS, a protein that drives tumor growth in most patients with pancreatic adenocarcinoma. The cancer arises from cells lining the ducts of the pancreas and is the most common form of pancreatic cancer.

“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, J.D. in the 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 said the action reflects its commitment to reducing unnecessary delays and advancing innovative treatments that can make a meaningful difference for patients and their families.

About 90% to 95% of the 67,000 new pancreatic cancer cases diagnosed in the United States each year are pancreatic adenocarcinoma, according to the National Cancer Institute. Although pancreatic adenocarcinoma accounts for roughly 3.2% of all cancer diagnoses, it represents a disproportionately high share of cancer deaths because it is typically detected late, follows an aggressive course and has historically had limited treatment options.

In a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months, compared with 6.7 months for standard chemotherapy.

“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence. “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 from the FDA and Priority Review for the indication. The application also was reviewed under the Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the review of therapies addressing national public health priorities.

In May, the FDA issued a “safe to proceed” letter allowing the sponsor to begin an expanded access treatment protocol for Rasonque. The protocol enabled patients to access the investigational drug before its approval under applicable FDA regulations.

The most common side effects reported with Rasonque are rash, diarrhea, stomatitis, or inflammation of the mouth’s mucus membranes, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.

The FDA granted the approval to Revolution Medicines, Inc.