FDA approves first oral drug for advanced pancreatic cancer

The U.S. Food and Drug Administration (FDA) has approved daraksonrasib (brand name Rasonque), the first oral medication for advanced or metastatic pancreatic cancer. Produced by Revolution Medicines, the daily pill targets the mutated KRAS gene, which is present in over 90 percent of pancreatic ductal adenocarcinoma (mPDAC) cases.

In a Phase 3 clinical trial involving 500 patients, the drug significantly improved survival outcomes. Patients receiving daraksonrasib had a median survival time of 13.2 months, compared to 6.7 months for those receiving standard chemotherapy. The FDA granted the drug ‘Breakthrough Therapy’ status in 2025 and approved it six months ahead of its regulatory deadline due to its unprecedented results in addressing a high unmet medical need.

Pancreatic cancer is notoriously difficult to treat, often diagnosed at late stages with a five-year survival rate of only 14 percent. Common side effects reported with this therapy include rash, diarrhea, nausea, and fatigue.