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Breakthrough Treatment for advanced Pancreatic Cancer - Approved by FDA

The U.S. Food and Drug Administration has approved the oral tablet Rasonque (daraxonrasib), a selective RAS genetic (mutation) inhibitor (present in more than 90% of those with pancreatic cancer) from the clinical oncology Revolution Medicines company.

Recent findings of a Phase III U.S. clinical trial with the orally administered FDA-designated “orphan drug” daraxonrasib, which acts as a selective RAS genetic (mutation) inhibitor, were reported out by Revolution Medicines in a press release in April 2026.

The results were highly encouraging in that those in the study (all with previously treated advanced ductal adenocarcinoma of the pancreas) who received just the oral daraxonrasib alone (daily, 300 mg) doubled their overall survival duration to 13.2 months as compared to those who otherwise received standard chemotherapy (6.7 months).

Side effects were observed to be mild to moderate consisting primarily of a rash, mouth sores, and/or GI signs & symptoms.

These findings are seen as not only a new approach to treatment, but importantly as a conceptual breakthrough utilizing known biology to fashion a more precise remedy. As such, the promise could lead to other important treatment progress. The high cost of Rasonque is a matter of some debate.

The respected oversight body NCCN (National Comprehensive Cancer Network) has presented updated guidelines for the treatment of pancreatic adenocarcinoma that include indications and guidance for the use of Rasonque.

The NCCN added daraxonrasib as a preferred option across a broader range of disease stages than the label alone conveys.

This includes:

• Treatment of patients with ECOG 0–2 performance status needing subsequent therapy for locally advanced disease, metastatic disease, or recurrent disease.

• Treatment of patients with recurrent metastatic disease after surgical resection if disease progression occurred within six months of completion of primary systemic therapy.

The Panel also added daraxonrasib as an option to be considered in certain circumstances for an even broader range of disease settings.

This includes:

• First–line treatment of patients with metastatic disease and ECOG 0-3 performance status.

• Treatment of patients with ECOG 3 performance status needing subsequent therapy for locally advanced disease, metastatic disease, or recurrent disease.