FDA approves a first-of-its-kind pill for advanced pancreatic cancer

The US Food and Drug Administration (FDA) on August 26, 2026 approved a daily pill for pancreatic cancer that has spread to other parts of the body¹. The drug, daraxonrasib, is sold by Revolution Medicines under the brand name Rasonque¹. It blocks a faulty protein called RAS that fuels tumor growth in more than 90% of pancreatic cancer cases, a target that drugmakers had failed to reach for decades¹.

In the study behind the approval, patients on the pill lived a median of 13.2 months, compared with 6.7 months for patients given chemotherapy¹. This is the first Biohack article on this drug.

What happened

The FDA cleared the pill for adults with metastatic pancreatic adenocarcinoma (the most common kind of pancreatic cancer, after it has spread) who have already had at least one earlier treatment, or who are not candidates for treatment with several cancer drugs combined². The company calls it the first broad RAS-targeted medicine for this cancer, and the first approved drug from a new class it calls RAS(ON) inhibitors².

The approval covers patients whether or not a RAS mutation has been found in their tumor, and it does not require a companion test before prescribing². That differs from drugs aimed at a single specific mutation, which need a test confirming that mutation first³.

The review was fast. The FDA accepted the application on July 22 and approved it 35 days later, about 6.5 months ahead of its target date, under a pilot program called the Commissioner’s National Priority Voucher³. That process is designed to shrink review times to as little as one to two months, from the usual 10 to 12⁴. “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 statement¹.

The evidence behind the approval

The approval rests on a trial called RASolute 302². It was a Phase 3 trial, the last big stage of testing before a drug can be approved, and it enrolled 500 patients⁵. All had cancer that had spread and had stopped responding to earlier treatment¹. Patients were randomly assigned to the pill or to more chemotherapy¹, with the chemotherapy chosen by the investigator from standard options². The trial was open-label, meaning patients and doctors knew which treatment was being given⁵.

The results, as reported by the company:

• Survival: a median of 13.2 months on the pill versus 6.7 months on chemotherapy, which the company describes as a 60% lower risk of death². “Median” means half of patients lived longer than that and half did not.
• Time before the cancer grew again: a median of 7.2 months on the pill versus 3.6 months on chemotherapy².
• Time on treatment: patients stayed on the pill a median of 6.2 months, against 1.5 to 3.2 months across the chemotherapy options³.

The company says the trial met all of its main goals, both in patients with a common RAS mutation and in the whole group². The results were presented at the American Society of Clinical Oncology meeting in 2026 and published at the same time in The New England Journal of Medicine². One small difference appears across sources: the drug’s own website gives the chemotherapy figure as 6.6 months rather than 6.7⁶.

For context, the American Cancer Society estimates about 67,000 new pancreatic cancer cases in the US this year and more than 52,000 deaths, with a five-year survival rate of 13%¹.

Side effects and how patients fared

Side effects included skin rash, mouth sores, diarrhea and other digestive problems¹. The company lists the most common ones, seen in at least 1 in 5 patients, as rash, diarrhea, mouth sores, nausea, vomiting, belly pain, swelling, lower appetite and bleeding². Rash and mouth sores were behind most dose reductions in the trial³.

Fewer patients stopped because of side effects: 1.2% on the pill versus 11.2% on chemotherapy³. CBS News reported fewer severe side effects with the pill than with chemotherapy¹.

Individual accounts have drawn attention. Former Senator Ben Sasse, diagnosed with stage-four pancreatic cancer, told “60 Minutes” he was in the trial and reported a 76% reduction in tumor volume over four months¹. Barbara Andes, 88, who began taking the pill in July after a year of chemotherapy, told Reuters it let her resume regular activities with far less nausea and fatigue⁴. These are personal reports, not trial results.

What it does not show yet

“This medicine is not a cure but a significant improvement,” said Dr. Andrew Coveler of the Fred Hutch Cancer Center¹.

Several questions remain open:

• Long-term results: median follow-up was 8.5 months, so it is not yet known how patients do over longer periods³.
• What comes next: nobody yet knows what treatment to give after the pill stops working, or how tumors become resistant to it³.
• Sicker patients: the trial enrolled people who were fairly active and able to care for themselves, but the approved use is wider and may include patients in poorer health whom the trial excluded³. How the drug works for them will be learned in everyday practice³.

Who is behind it

Revolution Medicines, based in Redwood City, California, developed the drug¹ and sponsored the trial⁵; CBS News describes the study as company-funded¹. The trial’s principal investigator was Brian Wolpin of the Dana-Farber Cancer Institute². “For patients and families facing metastatic pancreatic cancer, this approval represents a long-awaited and long deserved advance,” he said⁴.

The company chose not to sell the drug to a large drugmaker. In June 2025 it struck a $2 billion financing deal with Royalty Pharma, partly tied to future sales of daraxonrasib³. That same month, the FDA had granted the drug Breakthrough Therapy designation, a status meant to speed development of medicines that show early promise for serious diseases⁷.

Before approval, the FDA cleared an expanded access program in May, which lets patients get an unapproved drug outside a trial³. By August 5 the company had supplied doctors treating more than 2,000 patients in nearly all 50 states and Puerto Rico³.

How it fits the field

RAS mutations drive around 90% of pancreatic cancers, and scientists had been calling RAS “undruggable” for about 40 years, CBS News medical correspondent Dr. Céline Gounder said¹. A shape that made it hard for drugs to stick to the faulty protein kept it out of reach¹. Revolution’s drug works like a molecular glue that binds several kinds of KRAS, a member of the RAS family¹.

“I think this has opened doors for many other companies,” said Dr. Pashtoon Kasi of City of Hope Orange County¹.

What to watch next

• Earlier use: trials called RASolute 303 and 304 are testing the pill as a first treatment for spread cancer and after surgery³.
• Lung cancer: a trial in lung cancer with RAS mutations, RASolve 301, expects its first results in 2027³.
• Combinations: another trial pairs daraxonrasib with a second company drug, zoldonrasib, in pancreatic cancer with a specific mutation³.
• Other countries: the company says it is talking with regulators elsewhere about wider access².

Longer follow-up from the main trial will show whether the survival gap holds over time.