The U.S. Food and Drug Administration has approved the first-in-class targeted therapy Rasonque (daraxonrasib) for metastatic pancreatic cancer, opening a new treatment option for patients with one of the deadliest and hardest-to-treat forms of the disease.
The FDA recently announced the approval, saying the once-daily tablet reached patients months ahead of schedule after an accelerated review.
“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. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”
Rasonque targets multiple forms of RAS, a protein that drives tumor growth in most patients with pancreatic adenocarcinoma—the most common form of pancreatic cancer.
The approval covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
The approval is backed by a randomized, open-label, multicenter trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma.
Patients receiving Rasonque had a median overall survival of 13.2 months, compared with 6.7 months for those receiving standard chemotherapy.
“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, 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.”
The speed of the decision is a central feature of the approval. The FDA said Rasonque was cleared 6.5 months before its user fee deadline, reflecting the agency's push to accelerate access to treatments for serious and life-threatening diseases.
Pancreatic adenocarcinoma accounts for roughly 90% to 95% of the 67,000 pancreatic cancer cases diagnosed in the United States each year, according to the National Cancer Institute.
Although pancreatic adenocarcinoma represents only about 3.2% of all cancer diagnoses, it causes a disproportionately large share of cancer deaths. The disease is often detected late, progresses aggressively and has historically offered patients limited treatment options.
Rasonque is designed to attack one of the cancer's key biological drivers, potentially giving physicians another weapon after standard treatments have failed or are unsuitable.
