US FDA Approves Daraxonrasib for Pancreatic Cancer

The United States Food and Drug Administration (FDA) approved Rasonque (daraxonrasib) on 26 August 2026 for adult patients with metastatic pancreatic adenocarcinoma (PDAC). The drug is an oral daily pill developed by Revolution Medicines, Inc., a company based in Redwood City, California.

Pancreatic Adenocarcinoma

Pancreatic adenocarcinoma is the most common type of pancreatic cancer and is usually classified as an exocrine malignancy. Metastatic PDAC refers to cancer that has spread beyond the pancreas to other parts of the body.

Daraxonrasib and KRAS

Daraxonrasib is a multi-selective RAS(ON) inhibitor. It targets mutated KRAS, a gene alteration found in roughly 90% of pancreatic cancers. KRAS belongs to the RAS family of genes, which are involved in cell growth and signalling.

Clinical Trial and Regulatory Pathway

Phase 3 RASolute 302 clinical trial data showed a median overall survival of 13.2 months for patients taking daraxonrasib, compared with 6.7 months for those on standard chemotherapy. The FDA used the Real-Time Oncology Review (RTOR) pilot programme, and the review also involved collaboration with Health Canada under Project Orbis.

Important Facts for Exams

• Pancreatic adenocarcinoma is the most common histological type of pancreatic cancer.
• KRAS is one of the most frequently mutated oncogenes in human cancers.
• Project Orbis is an international framework for concurrent review of oncology medicines.
• Real-Time Oncology Review is an FDA programme for faster assessment of oncology applications.

Availability and Safety Profile

Rasonque is expected to be available in the United States by prescription at an approximate cost of $39,800 for a one-month supply. The reported common adverse effects include skin rash, mouth sores, diarrhoea, and digestive issues.