The U.S. Food and Drug Administration just approved a new breakthrough drug for pancreatic cancer that significantly extends the lives of people with the disease—considered one of the most intractable and difficult to treat forms of cancer.
The medication is called daraxonrasib and is manufactured by Revolution Medicines; it will be sold as Rasonque and takes the form of a two-pills-a-day regimen. It’s unclear how much the drug will cost.
The FDA approval makes the medication available to people with metastatic pancreatic cancer who have already been through chemotherapy. One of the great challenges of this form of cancer is that more traditional treatments, such as chemotherapy, tend to fail, especially at later stages of the disease. Tumors just stop responding or grow back, even while chemotherapy is ongoing.
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Daraxonrasib could make a radical difference. In a phase 3 clinical trial published earlier this year, 500 patients, most of whom had specific cancer-driving gene mutations and all of whom had previously treated metastatic pancreatic cancer, were assigned to receive daraxonrasib or chemotherapy. In the people with those mutations, median overall survival in the daraxonrasib group was 13.2 months, while the chemotherapy group had a median overall survival rate of 6.6 months. The survival rates were similar for the entirety of the participants (including those without the mutations)—13.2 months and 6.7 months for the daraxonrasib and chemotherapy groups, respectively.
"Daraxonrasib is a targeted treatment, not chemotherapy. It works differently from chemotherapy by targeting activated KRAS protein in pancreatic cancer cells," explains Kyaw Lwin Aung, a medical oncologist at Baptist Health Herbert Wertheim Cancer Institute. Aung was involved in the clinical trial showing daraxonrasib doubles survival time. In many cases of pancreatic cancer, mutations to the RAS protein leaves the gene stuck in the "on" position, telling cancer cells to keep growing. Daraxonrasib targets it.
"We can now envisage a future with no chemotherapy needed for pancreatic cancer patients. This is a remarkable milestone," Aung says.
Some patients who got the drug lived for years—something very few people with late-stage pancreatic cancer do. The cancer has the lowest five-year survival rate of any major cancer: around 13 percent.
Similar mutations are also found in other cancers, Aung says. "This approval also opens up opportunities for KRAS-targeted treatments for those with other cancers. We will see significant advances in the near future in KRAS-targeted therapy for other cancer types."
Revolution Medicines did not immediately respond to a request for comment.
Editor’s Note (8/26/26): This is a developing story and may be updated.