The Food and Drug Administration (FDA) on Wednesday approved Rasonque, a first-of-its-kind oral treatment for advanced pancreatic cancer that significantly extended survival in a late-stage clinical trial. The once-daily pill, developed by California-based Revolution Medicines and known generically as daraxonrasib, is now available by prescription in the United States. It is designed to block active forms of RAS, a family of proteins that drives tumor growth in most cases of pancreatic adenocarcinoma.
More than 90 percent of pancreatic cancers carry cancer-driving mutations in KRAS, a member of the RAS gene family that researchers once considered difficult to target with drugs. Shubham Pant, of MD Anderson Cancer Center and a trial investigator, has compared KRAS to "a shiny ball": "You can't stick anything to it. It just kind of slides off," Pant said in a recent interview with Managed Healthcare Executive.
Rasonque is the first approved medicine designed to broadly target the RAS pathway in pancreatic cancer. The FDA approved the treatment approximately 6 1/2 months before its user-fee deadline. The drug had received Breakthrough Therapy and Orphan Drug designations, Priority Review and consideration through the agency’s Commissioner’s National Priority Voucher pilot program.
"It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” the FDA's acting commissioner, Kyle Diamantas, said in a statement. Newsweek has reached out to Revolution Medicines via email on Wednesday afternoon for comment. Rasonque is approved for adults with metastatic pancreatic cancer whose disease has progressed after prior treatment or who are not candidates for standard combination chemotherapy.
The drug does not require a companion diagnostic test and can be used regardless of a patient's RAS mutation status. Before full approval, the FDA allowed Revolution Medicines to provide daraxonrasib through an expanded-access program for eligible patients with previously treated metastatic pancreatic cancer. reported that more than 2,000 patients had enrolled in the expanded-access program by the time of approval. Revolution Medicines set Rasonque’s wholesale acquisition cost at $39,800 for a 30-day supply at the recommended dosage.
The figure represents the drug’s list price, not necessarily the amount an individual patient will pay. Out-of-pocket costs will vary depending on insurance coverage and eligibility for financial assistance. The company said it is offering patient support through its (ON) Path program, while eligible patients with commercial insurance may qualify for copay assistance.
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