The FDA Approved a $39,800 Pancreatic Cancer Pill

The FDA on Wednesday approved Rasonque, a once-daily pill that doubled median survival for metastatic pancreatic cancer. The generic name is daraxonrasib, and it is the first RAS-targeted drug cleared for this disease.

Revolution Medicines priced a 30-day supply at $39,800. The approved use already covers some patients the Phase 3 trial never enrolled.

The Approved Label Reaches Past the Trial

The FDA approved Rasonque months ahead of schedule for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy, or who are not candidates for multiagent systemic therapy. That second clause is doing a lot of work. The registrational study, RASolute 302, enrolled people whose cancer had already grown after one line of treatment. It did not test the pill as a substitute for first-line combination chemotherapy in people judged too frail to receive it.

Acting FDA Commissioner Kyle Diamantas said the agency had a duty “to deliver more cures and meaningful treatments to patients as quickly as possible.” The review finished 6.5 months before the user-fee deadline, under Breakthrough Therapy, Orphan Drug, and Priority Review designations, plus the Commissioner’s National Priority Voucher pilot. In May the agency had already let the company open expanded access.

Revolution Medicines, based in Redwood City, California, said the approval does not require a companion diagnostic. Patients with or without an identified RAS tumor mutation can be prescribed the drug. Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute and the trial’s principal investigator, said more than 90 percent of pancreatic cancers carry cancer-driving mutations in KRAS, a RAS-family gene.

WHAT THE LABEL COVERS

• After prior therapy: Adults with metastatic pancreatic adenocarcinoma who already received at least one systemic regimen, matching the Phase 3 population.
• Too frail for combo chemo: Adults who are not candidates for multiagent systemic therapy, a group RASolute 302 did not enroll as first-line patients.
• No required gene test: The company said the medicine can be given with or without an identified RAS mutation and without a companion diagnostic.

WHAT IS STILL UNTESTED

• Fit first-line patients: Whether daraxonrasib beats or matches FOLFIRINOX-style chemotherapy when it is used from the start is the job of a separate ongoing study.
• The frail clause: Survival for newly diagnosed patients who skip combination chemotherapy because they cannot tolerate it was not the primary question in RASolute 302.
• Net price: Insurer discounts, Medicare terms, and how long typical patients stay on paid drug have not been disclosed.

Doctors reading that “not candidates” sentence already have a path to start the pill in people who never got a multi-drug regimen. That is a clinical judgment the label invites, and it is ahead of the first-line evidence.

What the 500-Patient Trial Showed

RASolute 302 randomized 500 adults with previously treated metastatic pancreatic adenocarcinoma, 1:1, to daraxonrasib or to the investigator’s choice of standard chemotherapy. The New England Journal of Medicine report said 248 patients got the pill and 252 got chemotherapy, and that 91.8 percent had RAS G12 mutations. Dual primary endpoints were overall survival and progression-free survival in the RAS G12 group, with the same measures in everyone enrolled.

The RAS G12 results sat almost on top of those figures: median overall survival 13.2 months versus 6.6 months, same hazard ratio of 0.40. Dana-Farber reported an objective response rate of 31.6 percent versus 11.2 percent in the full study, a slightly finer split than the FDA’s rounded 30 percent and 11 percent. The recommended dose is 300 mg by mouth once a day until the cancer grows or the side effects become too much.

Patients on the pill also kept their reported quality of life longer. Revolution said the median time to deterioration in global health status was 5.7 months against 2.6 months on chemotherapy, and time to worsening pain was 9.2 months against 3.8 months. The New England Journal of Medicine report said treatment-related side effects led 1.2 percent of patients on daraxonrasib to stop, against 11.2 percent on chemotherapy.

Median Survival Still Stops Short of 14 Months

A doubling of median survival is rare in this disease. It is also still a median of 13.2 months from the start of second-line therapy, with the upper end of the confidence interval not yet estimable. The FDA listed common side effects as rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

The American Cancer Society estimates 67,530 pancreatic cancer diagnoses this year in the United States, and about 52,740 deaths. The disease accounts for about 3 percent of cancers and about 8 percent of cancer deaths. ACS survival figures based on people diagnosed from 2015 to 2021 put five-year relative survival at 13 percent for all stages, 44 percent when the cancer is still confined to the pancreas, 17 percent when it has reached nearby tissue or nodes, and 3 percent when it has spread farther. The FDA, citing the National Cancer Institute, said about 90 to 95 percent of U.S. pancreatic cancers are adenocarcinoma, and that they make up roughly 3.2 percent of all cancer diagnoses.

Those five-year rates describe people treated years before this pill existed. They still explain why a 6.5-month gain in the second-line median landed as a landmark. First-line combination chemotherapy has lived in a narrower band. UCLA Health, reporting the NAPOLI-3 trial of NALIRIFOX, put median overall survival at 11.1 months against 9.2 months for gemcitabine plus nab-paclitaxel in untreated metastatic disease. Those clocks start at diagnosis of spread, not after the first regimen has already failed, so they are not a head-to-head with 13.2 versus 6.7. They do show why the next study matters: the newly approved pill has not yet proven it can replace that first-line mix in people who can take it.

Revolution Set the List Price at $39,800 a Month

The company said once-daily tablets now available in the United States carry a wholesale acquisition cost of $39,800 for a 30-day supply at the recommended dose. Twelve months at that list figure would be $477,600. Eligible commercially insured patients may pay as little as $0 with co-pay help through the company’s (ON)Path program, which the firm said will also handle coverage navigation and the shift off expanded access.

THE LAUNCH IN FOUR FIGURES

• List price: $39,800 for a 30-day supply at 300 mg once daily.
• Expanded access: Reuters reported more than 2,000 patients had enrolled in the pre-approval program by the time of clearance.
• Commercial copay: The company said eligible commercially insured patients may pay as little as $0.
• Near-term sales: Reuters cited RBC Capital Markets as estimating about $28 million in U.S. pancreatic cancer revenue in the third quarter, helped by those expanded-access patients.

Reuters also said Revolution shares were relatively flat at $211.70 on the news, after a 166 percent rise this year, because investors had already treated approval as likely. Anna Berkenblit, chief scientific and medical officer of the Pancreatic Cancer Action Network, called an oral pill less burdensome than standard intravenous chemotherapy. The list price still sits on a Medicare-heavy illness in which many patients will need the assistance program, not a commercial copay card, to start at all.

Former U.S. senator Ben Sasse of Nebraska described on CBS’s 60 Minutes, the Guardian noted, that he has had less pain while taking the then-investigational drug. That public account, plus the April readout, is what pushed demand into the expanded-access queue before Wednesday’s decision.

Blocking RAS Took Decades of Failed Chemistry

RAS is a growth-control switch. When it is stuck on, it drives tumor growth. Drugmakers spent decades trying to shut it off, and pancreatic cancer became the emblem of that failure because the mutation is so common there. Daraxonrasib is an oral RAS(ON) multi-selective tri-complex inhibitor. Dana-Farber said it acts as a molecular glue with another protein, cyclophilin A, and blocks RAS signaling. It hits both mutant and wild-type RAS in the active, GTP-bound state.

For many years, researchers believed that successfully targeting RAS had the potential to transform the treatment of pancreatic cancer, but therapeutically blocking RAS signaling proved extraordinarily challenging. The FDA approval of daraxonrasib represents a landmark advance for patients with metastatic pancreatic cancer.

Brian Wolpin, M.D., M.P.H., director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, in a Dana-Farber statement

Mark A. Goldsmith, M.D., Ph.D., chief executive of Revolution Medicines, called RAS “one of the most intractable disease targets since its discovery decades ago.” Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence, said the drug “showed unprecedented results in an area of high unmet need.”

HOW THE PILL GOT HERE

1. March 9, 2026: Revolution opens RASolute 303, a three-arm first-line study of daraxonrasib alone or with gemcitabine and nab-paclitaxel against that chemotherapy pair.
2. April 2026: The company reports that RASolute 302 hit its survival goals, and demand for expanded access jumps.
3. May 2026: The FDA issues a “safe to proceed” letter for an expanded-access protocol.
4. May 31, 2026: Wolpin presents RASolute 302 in the ASCO plenary; the New England Journal of Medicine publishes the trial.
5. August 26, 2026: The FDA approves Rasonque for metastatic pancreatic adenocarcinoma in the two groups named on the label.

Earlier RAS work in other tumors, including KRAS G12C drugs in lung cancer, never produced a result like this in pancreatic adenocarcinoma. The chemistry problem was the G12D and G12V variants that dominate this disease. A multi-selective RAS(ON) inhibitor is the bet that those variants are finally in range.

A First-Line Trial Started in March

The first-line RASolute 303 trial is a global, open-label Phase 3 study with three arms: daraxonrasib alone, daraxonrasib plus gemcitabine and nab-paclitaxel, and gemcitabine plus nab-paclitaxel. ClinicalTrials.gov lists the actual start date as March 9, 2026. Until that study reads out, combination chemotherapy remains the proven first treatment for fit patients with metastatic disease.

The FDA prescribing information includes warnings for perforation and lung injury, along with dermatologic and soft tissue toxicity, stomatitis and other oral disorders, diarrhea, and embryo-fetal toxicity. Interstitial lung disease and pneumonitis sit in that warning list. Project Orbis ran in parallel with Health Canada; the European Medicines Agency and Japan’s PMDA were official observers. Revolution said the drug remains investigational outside the United States, with a phased EMA review underway. The company also holds Breakthrough Therapy designation in previously treated KRAS-mutant non-small cell lung cancer that is not G12C.

FDA WARNING LIST

• Skin and soft tissue: Dermatologic and soft tissue toxicity, with rash among the most common effects.
• Mouth and gut: Stomatitis, diarrhea, and a warning for gastrointestinal perforation.
• Lungs: Interstitial lung disease and pneumonitis.
• Pregnancy: Embryo-fetal toxicity, which means the label carries counseling duties for anyone who could become pregnant.

A Phase 1/2 New England Journal of Medicine paper on previously treated RAS-mutated pancreatic cancer said grade 3 or higher treatment-related adverse events occurred in one third of those patients. That is the safety floor doctors will watch as expanded-access patients convert to commercial supply.

The live clinical question is no longer whether RAS blockade can beat second-line chemotherapy. It is how soon people who cannot take a multi-drug regimen will be started on the pill, and whether RASolute 303 later moves it in front of chemotherapy for everyone else. The 303 study is already open. Until it reports, the approved use is a once-daily tablet after prior therapy, or when combination chemotherapy is off the table.

Frequently Asked Questions

Does Rasonque Require a RAS Gene Test Before Treatment?

No. Revolution Medicines said the approval covers adults with metastatic pancreatic adenocarcinoma with or without an identified RAS tumor mutation and does not require a companion diagnostic. RASolute 302 still enrolled a heavily RAS G12 group (91.8 percent), and the FDA said the survival benefit held in both that subgroup and the full enrolled population, which included less common RAS variants and patients with no RAS mutation identified.

Is Rasonque Approved Outside the United States?

Not yet. The company said daraxonrasib remains an investigational agent outside the U.S. The FDA review ran under Project Orbis with Health Canada as a partner, while the EMA and Japan’s PMDA observed. The EMA’s Committee for Medicinal Products for Human Use has started a phased review, and the drug has EU orphan designation for pancreatic cancer plus high-priority status under the EMA Cancer Medicines Pathfinder project.

What Other Cancers Is Daraxonrasib Being Studied In?

Revolution is running a global Phase 3 program in metastatic RAS-mutant non-small cell lung cancer as well as pancreatic adenocarcinoma. The FDA has already granted Breakthrough Therapy designation for previously treated, locally advanced or metastatic NSCLC with KRAS mutations other than G12C after platinum chemotherapy and PD-(L)1 antibody therapy. The pancreatic label on Wednesday does not cover lung cancer.

How Long Do Patients Take the 300 mg Dose?

The FDA recommended 300 mg orally once daily until disease progression or unacceptable toxicity, not a fixed number of cycles. In the earlier Phase 1/2 study of previously treated RAS-mutated pancreatic cancer, a 26-patient RAS G12 subgroup treated at 300 mg in the second line had a median duration of response of 8.2 months and median overall survival of 13.1 months, according to the New England Journal of Medicine report on that earlier trial.

Disclaimer: This article is news reporting on an FDA drug approval and related trial results, and it is for information only. It is not medical advice, a treatment recommendation, or a substitute for a conversation with an oncologist about whether daraxonrasib is appropriate for a given patient. Anyone considering this medicine should consult a qualified cancer specialist and, for coverage questions, the insurer or a pharmacist before starting, stopping, or paying for therapy. Survival figures, list prices, eligibility rules, and trial statuses reflect the FDA, company, and American Cancer Society sources as of August 27, 2026, and may change.