The U.S. Food and Drug Administration (FDA) has approved daraxonrasib, a new twice-daily pill designed to treat pancreatic cancer. The drug targets the KRAS genetic mutation, which is present in nearly 90 percent of pancreatic cancer cases and drives their growth.
This approval marks a significant development for pancreatic cancer patients, offering a doubling of survival odds in clinical trials. The drug is indicated for patients with metastatic pancreatic cancer who have previously undergone chemotherapy.
In a pivotal clinical trial, patients treated with daraxonrasib lived an average of 13 months, nearly double the survival time of those receiving standard chemotherapy. Some participants in the trial reportedly lived for several years on the treatment. While not a cure, daraxonrasib offers a substantial improvement for one of the deadliest cancers, which has a five-year survival rate of less than 10 percent.
"We've never seen a benefit like this," stated Dr. Anna Berkenblit, chief scientific and medical officer at the Pancreatic Cancer Action Network.
Revolution Medicines, the drug's manufacturer, will market daraxonrasib under the brand name Rasonque. The company has not yet disclosed the drug's cost. However, since May, more than 2,000 patients have received early access to the medication through the FDA's expanded access program. These patients will transition to insurance coverage as their supply is managed by Revolution Medicines.
Pancreatic cancer affects approximately 67,000 Americans annually and leads to 52,000 deaths each year, according to the American Cancer Society. Historically considered a disease predominantly affecting older adults, there has been a noted increase in diagnoses among younger individuals in their 20s, 30s, and 40s, often without the presence of traditional risk factors like smoking, obesity, or type 2 diabetes.