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0 Share Newsweek is a Trust Project member See more of our trusted coverage when you search. Prefer Newsweek on Google to see more of our trusted coverage when you search. 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.
Dr. 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. Reuters 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, with some privately insured patients potentially paying as little as $0 with their co-pay.
Anna Berkenblit, chief scientific and medical officer at the Pancreatic Cancer Action Network (PanCAN), said the organization is concerned about the potential out-of-pocket costs associated with new pancreatic cancer treatments.
"The potential financial burden of new therapies for pancreatic cancer patients, including what they may ultimately face in out-of-pocket costs, is an issue that PanCAN is concerned about," Berkenbilt told Newsweek via email. "Cost should not become a barrier to patients who may benefit from a new treatment."
She added that PanCAN's Patient Services program helps patients navigate treatment decisions and identify resources that may ease financial and access challenges.
In addition, Revolution said it is offering patient support through its (ON) Path program.
Patients who received Rasonque lived a median of 13.2 months, compared with 6.7 months for those treated with chemotherapy. The drug reduced the risk of death by 60 percent and also delayed disease progression.
“This is not a cure, it’s one more option for these patients,” said Dr. Pashtoon Kasi of City of Hope Orange County, a California-based cancer center. “But it’s the best option we’ve ever had.”
Rasonque was associated with fewer severe side effects than chemotherapy. Common ones included rash, diarrhea, mouth sores, nausea, fatigue, vomiting and abdominal pain. While the treatment is not a cure, specialists said the results represent a significant advance for patients with metastatic pancreatic cancer, a disease that has long had limited treatment options.
Pancreatic cancer is often not detected until it has spread and remains one of the deadliest forms of cancer. The American Cancer Society estimates that more than 52,000 people in the United States will die from the disease in 2026.
The drug was unveiled by lead investigator Dr. Brian M. Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, during the plenary session of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on May 31.
When Wolpin advanced to a slide showing that the once-daily pill cut the risk of death by 60 percent in patients with previously treated metastatic pancreatic cancer, the packed auditorium erupted as attendees cheered, whistled and applauded.
"That time was not built into my talk," Wolpin quipped from the stage once the ovation finally subsided.
Video clips of the ovation received millions of views on social media.
"Seldom do you sense you’re witnessing a historic moment in cancer care but this feels like RAS targeting has arrived," wrote Dr. Mark Lewis, director of gastrointestinal oncology at Intermountain Healthcare, on X. "One of the most amazing things I’ve ever seen: a standing ovation for the full Daraxonrasib results," wrote Dr. Samuel Hume, cofounder of Stematic Labs, which uses AI tools for scientific discovery.
The drug garnered public attention when former U.S. Republican Senator Ben Sasse of Nebraska described on 60 Minutes how he's had less pain while taking it.
“I think this has opened doors for many other companies,” Kasi said. “Downstream I think there are going to be...
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