In a significant medical breakthrough, the U.S. Food and Drug Administration (FDA) has granted approval to a new drug poised to enhance survival rates for individuals battling metastatic pancreatic cancer.
Revolution Medicines will market the drug as Rasonque, with its scientific designation of daraxonrasib. This innovative daily medication is designed to target the RAS protein family, notorious for its role in fueling tumor growth.
In an extensive clinical trial involving 500 participants, results were compelling. The median overall survival time for patients nearly doubled, reaching over 13 months, compared to about 6.7 months with traditional chemotherapy.
Dr. Brian Wolpin, head of the Hale Family Center for Pancreatic Cancer Research at the Dana-Farber Cancer Institute, expressed the significance of this approval in a statement to ABC News, highlighting it as a landmark achievement born from years of dedication to targeting the KRAS pathway.
“This approval presents a novel treatment avenue and renewed hope for those suffering from metastatic pancreatic cancer,” Dr. Wolpin remarked, emphasizing that the breakthrough forms a vital foundation for further advances against one of the most challenging cancers known today.
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.”
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