FDA approves Rasonque, the first oral therapy targeting the RAS pathway in pancreatic cancer

The FDA has approved Rasonque, a daily pill from Revolution Medicines for adults with previously treated metastatic pancreatic cancer. The drug showed a median survival of 13.2 months compared to 6.7 months with chemotherapy, although its list price amounts to USD $39,800 for a 30-day supply.

• Rasonque, whose generic name is daraxonrasib, is now available by prescription in the United States for certain adults with metastatic pancreatic cancer.
• In the phase 3 RASolute 302 trial, the treatment reduced the risk of death by 60% compared to chemotherapy and delayed disease progression.
• Revolution Medicines set a wholesale price of USD $39,800 per month, while out-of-pocket costs will depend on insurance and assistance programs.

The U.S. Food and Drug Administration has approved Rasonque, an oral treatment taken once daily developed by Revolution Medicines for adults with metastatic pancreatic cancer. The medication, generically known as daraxonrasib, is now available by prescription in the United States and represents the first approved treatment designed to broadly target the RAS pathway in this type of tumor.

The authorization is supported by results from a phase 3 clinical trial that showed a median survival of 13.2 months among patients treated with Rasonque, compared to 6.7 months among those receiving chemotherapy. The drug also reduced the risk of death by 60% and delayed disease progression, although specialists emphasized that it does not constitute a cure for advanced pancreatic cancer.

What the FDA approved and who can receive it

Rasonque is indicated for adults with metastatic pancreatic cancer whose disease has progressed after prior treatment or who are not candidates for standard combination chemotherapy. The approval does not require a complementary diagnostic test and allows the treatment to be used regardless of the patient’s RAS mutation status.

The decision came approximately six and a half months ahead of the review deadline associated with the agency’s user fees. Before the full approval, the FDA had allowed Revolution Medicines to supply 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 that program when the FDA authorized the drug. The treatment had also received designations of Breakthrough Therapy and Orphan Drug, as well as Priority Review and consideration within the National Priority Coupons pilot program of the Commissioner.

Acting FDA Commissioner Kyle Diamantas stated in a release that providing meaningful treatments to patients more quickly is part of the agency’s core duty. Revolution Medicines, based in California, had not immediately responded to a request for comment sent by Newsweek on Wednesday afternoon.

The RAS pathway reaches pancreatic cancer

The scientific relevance of Rasonque is linked to the historical difficulty of targeting RAS proteins, which are involved in the signals that drive tumor growth. More than 90% of pancreatic cancers have driver mutations in KRAS, a member of the RAS gene family that has long been considered particularly difficult to block with drugs.

Dr. Shubham Pant from the MD Anderson Cancer Center and investigator of the trial compared KRAS to a shiny ball that nothing can stick to because it simply slips away. Daraxonrasib aims to intervene in the active forms of RAS, a strategy that, according to the results released, expands the treatment’s reach beyond a single specific mutation.

The phase 3 RASolute 302 trial included 500 adults with previously treated metastatic pancreatic cancer. The survival difference compared to chemotherapy drew attention during the annual meeting of the American Society of Clinical Oncology in 2026, held in Chicago on May 31.

Brian M. Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at the Dana-Farber Cancer Institute and principal investigator of the study, presented the full results during the plenary session. When he showed that the daily pill reduced the risk of death by 60%, the audience responded with an ovation that lasted longer than expected during his presentation.

Survival, Side Effects, and Expectations

The results make Rasonque a relevant option for patients who have already received treatment or cannot undergo the standard combination of chemotherapy. Dr. Pashtoon Kasi from City of Hope Orange County stated that the drug is not a cure but described it as the best available alternative so far for this group of patients.

The treatment was associated with fewer severe side effects than chemotherapy in the trial. Common adverse reactions included rash, diarrhea, mouth sores, nausea, fatigue, vomiting, and abdominal pain, so the decision to use it should consider each patient’s clinical situation.

Pancreatic cancer is often detected when it has already spread and remains one of the deadliest tumors. The American Cancer Society estimates that more than 52,000 people will die from this disease in the United States during 2026, a reality that helps explain the expectation generated by a therapy with results superior to those of the trial comparator.

Experts cited in the original information noted that the success of daraxonrasib could stimulate new trials to study the approach in other types of tumors. Mark Lewis, director of gastrointestinal oncology at Intermountain Healthcare, called the targeting of RAS a historic moment, while Samuel Hume, co-founder of Stematic Labs, described the ovation for the results as one of the most astonishing scenes he had witnessed.

Price, Insurance, and Patient Access

Revolution Medicines set the wholesale acquisition cost of Rasonque at USD $39,800 for a 30-day supply at the recommended dose. This amount corresponds to the list price and does not determine how much each patient will pay, as final payments will depend on the type of insurance, coverage conditions, and eligibility for assistance programs.

The company indicated that some patients with commercial insurance could pay as little as USD $0 through copay assistance programs. Since it is an oral therapy administered at home, it is expected to generally fall under the Part D prescription drug benefit of Medicare, rather than Part B, which typically covers treatments administered by physicians, such as infusions.

The Pancreatic Cancer Action Network noted that the FDA does not directly decide on insurance coverage, although agency approval usually facilitates Medicare and Medicaid covering a drug. However, insurers maintain the decision on their reimbursement policies and the copayment that each patient will ultimately face.

Anna Berkenblit, scientific and medical director of PanCAN, warned that the organization will monitor the potential financial impact of new therapies for pancreatic cancer. She also stated that cost should not become a barrier for individuals who could benefit from the treatment, while PanCAN offers guidance and connection to resources through its Patient Services Program.

Revolution Medicines stated that it will complement this support through its ON Path program. Commercial availability resolves the uncertainty about when Rasonque can be obtained, but effective access will still depend on medical prescription, insurance approval, and the assistance mechanisms available for each patient.

An Approval That Captured Public Attention

Daraxonrasib gained public visibility after former U.S. Republican Senator Ben Sasse from Nebraska described on the program 60 Minutes that he felt less pain while taking the medication. His testimony brought the discussion of an experimental therapy, which was later approved, to a broader audience, beyond medical congresses and specialized circles.

The reaction during Wolpin’s presentation also amplified interest on social media, where videos of the applause reached millions of views. Kasi noted that the drug opened doors for other companies and anticipated that more studies on the same strategy in different tumors could emerge.

The approval does not eliminate the severity of pancreatic cancer nor guarantee the same benefit for all patients. Its significance lies in offering an oral option with a substantial survival improvement in a phase 3 trial, while forcing the healthcare system to resolve how to finance a therapy whose list price can reach USD $39,800 per month.

The next challenge will be to convert clinical results into sustained access and adequate medical follow-up. For patients with previously treated metastatic disease, Rasonque adds an alternative that seemed unlikely for years when researchers described KRAS as a practically elusive target.