The U.S. Food and Drug Administration approved Rasonque on Wednesday, a first-of-its-kind treatment for pancreatic adenocarcinoma, the most common form of pancreatic cancer — months ahead of its scheduled review deadline.
Rasonque is a once-daily tablet that targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma, a cancer that arises from cells lining the ducts of the pancreas.
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In a randomized clinical trial involving 500 patients with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival from 6.7 months to 13.2 months, compared to standard chemotherapy.
"This drug showed unprecedented results in an area of high unmet need," 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."
The approval covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
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Approximately 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the U.S. each year are pancreatic adenocarcinoma, according to the National Cancer Institute. 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.
Acting FDA Commissioner Kyle Diamantas said the approval marks a significant step forward for patients.
"Today's approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer," Diamantas said. "It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible."
