WASHINGTON, D.C. — The Food and Drug Administration approved Revolution Medicines Inc.’s Rasonque for certain adults with metastatic pancreatic adenocarcinoma after a clinical trial showed the drug nearly doubled median overall survival compared with standard chemotherapy, adding a treatment option for one of the deadliest major cancers.
Rasonque, also known as daraxonrasib, is approved for adults who have received at least one previous systemic therapy or are not candidates for multiagent systemic therapy, the FDA reported. The once-daily tablet inhibits multiple forms of RAS, a protein that drives tumor growth in most patients with pancreatic adenocarcinoma.
In a randomized, open-label trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, median overall survival reached 13.2 months among patients receiving Rasonque, compared with 6.7 months for those receiving 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, stated.
The approval came 6.5 months before the agency’s user-fee deadline, according to de Claro, following an expedited regulatory process that included Breakthrough Therapy and Orphan Drug designations and Priority Review.
The application was also reviewed through the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate reviews of therapies addressing designated national public-health priorities.
Pancreatic adenocarcinoma accounts for an estimated 90% to 95% of the roughly 67,000 new pancreatic cancer cases diagnosed annually in the U.S., according to National Cancer Institute data cited by the FDA.
Although pancreatic cancer represents about 3.2% of cancer diagnoses, pancreatic adenocarcinoma contributes disproportionately to cancer mortality because it is frequently detected late, progresses aggressively and historically has had limited treatment options.
“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer,” Acting FDA Commissioner Kyle Diamantas stated.
The FDA had issued a “safe to proceed” letter in May allowing Revolution Medicines to initiate an expanded-access treatment protocol, providing qualifying patients access to the investigational drug before its approval under applicable federal regulations.
The most commonly reported side effects of Rasonque include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.
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