On Aug. 26, 2026, the US Food and Drug Administration (FDA) approved Revolution Medicines’ Rasonque™ (daraxonrasib) for the treatment of adults who have metastatic pancreatic adenocarcinoma (PDAC) and have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Rasonque is a first-in-class, oral Rat sarcoma (RAS)(ON) inhibitor that targets multiple forms of the RAS protein, a key driver of tumor growth in most pancreatic adenocarcinomas. Unlike therapies that target a single RAS mutation, Rasonque is designed to inhibit both wild-type and mutant RAS proteins in their active state, reducing downstream signaling associated with tumor growth. The recommended dose is 300mg orally once daily. Tablets may be taken with or without food and should be swallowed whole. The prescribing information recommends prophylactic and concomitant medications to reduce the risk of skin reactions. Revolution Medicines states that Rasonque is launching today; it will cost approximately $39,800 per month. Here is the prescribing information.
At a Glance
- Brand Drug: Rasonque™ (daraxonrasib)
- Manufacturer: Revolution Medicines
- Date Approved: Aug. 26, 2026
- Indication: For the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy
- Dosage Forms Available: 100mg and 150mg tablets
- Launch Date: Upon approval.
- Estimated Annual Cost: $477,600
- FDA Designation: Breakthrough Therapy. Orphan Drug. Priority Review. Commissioner’s National Priority Voucher.
- Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer that is often diagnosed at an advanced stage and remains a leading cause of cancer-related mortality, with limited treatment options and poor survival outcomes in metastatic disease.
- Approximately 55,000 new cases of pancreatic cancer are diagnosed annually in the US, with PDAC accounting for 90-95% of cases.
- Approval was supported by a 500-patient randomized, open-label, multicenter trial in previously treated metastatic PDAC, where Rasonque demonstrated a median overall survival of 13.2 months compared with 6.7 months for standard chemotherapy.
- The most common adverse reactions reported were rash, diarrhea, nausea, and fatigue.
- Historically, PDAC has been treated primarily with chemotherapy-based regimens. This is the first approved multiselective RAS inhibitor for this patient population.
- The FDA previously permitted expanded access to Rasonque, allowing eligible patients with PDAC to receive the investigational therapy before its regulatory review was completed.
- Rasonque is being studied in additional RAS-driven cancers and earlier lines of therapy, including a phase III program in previously treated RAS-mutant non-small cell lung cancer.