FDA approves Razonque, first KRAS-targeting drug for pancreatic cancer
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The U.S. Food and Drug Administration approved Razonque (daraxonrasib), a daily pill targeting the KRAS gene, for previously treated metastatic pancreatic cancer. In a 500-patient trial, Razonque extended median survival to 13 months versus 6 months for chemotherapy. The approval marks the first KRAS-targeted therapy for pancreatic cancer.
Key Facts
- The FDA approved Razonque (daraxonrasib) for previously treated metastatic pancreatic cancer on August 27, 2026.
- In a 500-patient trial, Razonque extended median survival to 13 months versus 6 months for chemotherapy.
- Razonque is manufactured by Revolution Medicines and is taken daily.
- The drug targets the KRAS gene, which is common in pancreatic cancer and resistant to traditional treatments.
- Trial results were presented at the American Society of Clinical Oncology meeting, where attendees gave a standing ovation.
Approval and Trial Data
The FDA approved Razonque (daraxonrasib) for patients with metastatic pancreatic cancer who have received prior treatment. The approval is based on a trial of 500 patients comparing Razonque to chemotherapy. Patients receiving Razonque had a median survival of 13 months, compared to 6 months for those on chemotherapy. Razonque is manufactured by Revolution Medicines and is administered as a daily pill.
Mechanism and Significance
Razonque targets the KRAS gene, which regulates cell growth and is commonly mutated in pancreatic cancer. The KRAS gene has long been considered a key target in cancer therapy but has shown high resistance to traditional treatments. Daraxonrasib blocks the activity of proteins produced by the KRAS gene, stopping cancer cell growth. Researchers described the approval as a turning point in pancreatic cancer treatment. Trial results were presented at the American Society of Clinical Oncology meeting, where attendees gave a standing ovation.
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FDA approves Razonque, first KRAS-targeting drug for pancreatic cancer
