Experimental drug daraxonrasib nearly doubles survival time for pancreatic cancer patients in clinical trial

May 31, 2026

An experimental pill, daraxonrasib, nearly doubled survival time for advanced pancreatic cancer patients to 13.2 months versus 6.7 for chemotherapy in a major clinical trial. The drug targets the KRAS gene mutation, present in over 90% of cases and long considered "undruggable." Hailed as a "game changer" by oncologists, the drug is now available to some patients via an FDA expanded access program ahead of an expected expedited approval.

Daraxonrasib Phase 3 trial results

▪The clinical trial involved 500 patients with metastatic pancreatic cancer whose disease had stopped responding to prior treatment.
▪In a Phase 3 trial, the drug daraxonrasib extended median survival for advanced pancreatic cancer patients to 13.2 months, compared to 6.7 months for chemotherapy.
▪Oncologists hailed the results as a "game changer" and "unprecedented," with one expert reporting she cried with joy upon seeing the data.
▪The most common severe side effects for daraxonrasib were a severe rash and mouth sores.
▪Patients taking daraxonrasib experienced fewer severe side effects (43.6%) than those on chemotherapy (57.5%).

KRAS mutation targeting mechanism

▪The KRAS protein was long considered "undruggable" because its smooth structure made it difficult for drugs to attach.
▪Daraxonrasib targets a mutated KRAS protein that fuels tumor growth in over 90% of pancreatic cancer cases.
▪Daraxonrasib acts as a "molecular glue," binding with a protein called cyclophilin A to then attach to and shut down the KRAS protein.

Pancreatic cancer survival rates

▪The American Cancer Society estimates 67,000 new U.S. cases and over 52,000 deaths from pancreatic cancer will occur this year.
▪For patients with metastatic pancreatic cancer, where the disease has spread, the five-year survival rate is 3%.
▪Pancreatic cancer has one of the highest mortality rates of all major cancers, with a 13% five-year overall survival rate.

Patient experiences with daraxonrasib

▪Former U.S. Senator Ben Sasse reported a 76% reduction in tumor volume and less pain after four months on daraxonrasib.
▪Patients taking daraxonrasib reported less pain and a better quality of life as their tumors shrank.
▪Debby Orcutt, a clinical trial participant, experienced an 80% reduction in her pancreatic tumor and the disappearance of a cancerous spot on her liver.

FDA expanded access program

▪The FDA has granted an "expanded access" program, allowing some patients to receive daraxonrasib outside of clinical trials before full approval.
▪The expanded access program has triggered a "deluge" of patient requests for the drug at cancer centers.
▪The FDA plans to expedite its review of daraxonrasib, which could lead to full approval within a month or two after the manufacturer files its application.

Future applications across cancers

▪The KRAS gene mutation is also a driver in other cancers, including lung and colorectal cancer, suggesting potential for daraxonrasib's broader use.
▪Researchers plan to study daraxonrasib's use earlier in the disease to potentially shrink tumors enough for surgery.