FDA approves breakthrough drug to treat advanced pancreatic cancer
The Food and Drug Administration (FDA) approved on Wednesday a drug that could extend the survival of those with metastatic pancreatic cancer.
The drug, called daraxonrasib, will be sold under the brand name Rasonque from Revolution Medicines. The daily pill targets multiple forms of a protein called RAS, which is a main driver of tumor growth.
A late-stage clinical trial with 500 patients showed that the median overall survival nearly doubled to more than 13 months versus a median survival of about 6.7 months for those being treated with standard chemotherapy.
"FDA approval of daraxonrasib is an exceptional moment for patients with pancreatic cancer and the culmination of many years of research to find a way to target KRAS," Dr. Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at the Dana-Farber Cancer Institute, told ABC News in a statement.
"It brings a new treatment option and new hope to patients with metastatic pancreatic cancer, while giving us a foundation to make many more advances against this difficult disease," the statement continued.
About 95% of exocrine pancreatic cancers in the U.S. are pancreatic adenocarcinoma, according to the American Cancer Society.
Although pancreatic adenocarcinoma represents only about 3.2% of all cancer diagnoses, it accounts for a disproportionately high share of cancer deaths, according to the FDA.
This is due to several factors including late detection, aggressive disease course and historically limited treatment options, the federal health agency said.
In June 2025, the FDA granted the drug a "Breakthrough Therapy" designation. This allows for expedited development and review of drugs that treat serious conditions and have preliminary evidence showing substantial improvement over available treatments.
The application was reviewed under the Commissioner's National Priority Voucher Program, initiated by former FDA Commissioner Dr. Marty Makary. The review time was accelerated from 12 months to 10 months.
There is hope that this new type of targeted treatment will show benefits for other hard-to-treat cancers.
"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 in a press release. "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 FDA approval was granted for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or cancer treatments that target the entire body. Other drug candidates also include those getting multiagent systemic therapy, meaning two or more treatments.
Patients who participated in the clinical trial told "Good Morning America" in June that the drug renewed optimism about their prognoses.
One patient named Jim said that after beginning treatment with daraxonrasib, a tumor in his liver that had spread from his pancreas shrank significantly.
"The tumor that I had in my liver, which had spread from the pancreas, got reduced by 50%, which was incredible news," he told "GMA."
