The U.S. Food and Drug Administration has granted expanded access to daraxonrasib, an experimental pill for patients with advanced pancreatic cancer [2].
This decision follows trial results that suggest a significant increase in survival rates for a disease known for its low five-year survival and limited treatment options [1].
Daraxonrasib is an oral KRAS-G12D inhibitor. In clinical trials, the drug showed that median overall survival was approximately 7.6 months, compared to 4.6 months for those receiving standard chemotherapy [1].
"Daraxonrasib nearly doubled patients' survival time in the trial," said Dr. Michael J. Koren, the lead investigator [1].
The trial was conducted across multiple cancer centers in the U.S., and the FDA's expanded-access program now allows eligible patients nationwide to seek the treatment [2]. The drug targets specific genetic mutations to slow the progression of the disease.
Medical professionals cautioned that the treatment is not a cure. "While not curing the cancer, it is a very large step forward for patients with this disease," said Dr. Sarah L. Patel, an oncologist at the trial site [3].
A spokesperson for the research team said a novel pill helped people with advanced pancreatic cancer live longer, raising hopes for better treatments [2]. The results were first presented in late May 2024 [1].
“"Daraxonrasib nearly doubled patients' survival time in the trial."”
The FDA's decision to grant expanded access allows patients with life-threatening conditions to use an investigational drug outside of a formal clinical trial when no comparable alternative therapy exists. While the survival increase is statistically significant, the focus remains on managing a highly aggressive cancer rather than achieving total remission. This shift toward targeted KRAS inhibitors could establish a new baseline for how advanced pancreatic cancer is treated in the U.S.
