FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer

Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior therapy.

The approval follows striking clinical results presented at the American Society of Clinical Oncology meeting in May, where the data earned a standing ovation from attendees.

The agency reviewed the application through its Commissioner’s National Priority Voucher program, and FDA Oncology Center of Excellence director Angelo de Claro highlighted the unprecedented outcomes in a disease with high unmet need. Acting FDA Commissioner Kyle Diamantas called the drug a critical new option for a historically hard-to-treat cancer.

Revolution Medicines plans to seek earlier-line indications for Rasonque and continues to develop additional RAS inhibitors in its pipeline.