FDA approves Rasonque, doubling survival in advanced pancreatic cancer

The U.S. Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a first-in-class oral therapy for adults with metastatic pancreatic adenocarcinoma, marking the first major advance against this aggressive cancer in decades. The approval, announced Wednesday, is based on a Phase III trial showing a median overall survival of 13.2 months for Rasonque versus 6.7 months for standard chemotherapy—nearly doubling survival Source: Infobae.

How it works

Rasonque is a RAS inhibitor that targets multiple variants of the RAS protein, which drives tumor growth in most pancreatic cancers. Unlike traditional chemotherapy, it acts selectively, minimizing damage to healthy tissues Source: Excelsior. The drug is taken once daily as a pill Source: Herald of Mexico.

Clinical evidence

The FDA's approval was supported by an open-label, randomized, multicenter trial involving 500 previously treated adults Source: Infobae. Results presented at ASCO 2026 and published in the New England Journal of Medicine showed the survival benefit Source: La Voz. The FDA granted Rasonque Breakthrough Therapy, Orphan Drug, and Priority Review designations, and approved it 6.5 months ahead of schedule Source: Herald of Mexico.

Eligibility and availability

Rasonque is indicated for patients who have received at least one prior systemic therapy or who are not candidates for combination chemotherapy Source: Diario Libre. The FDA emphasized that it is not a cure Source: Emol. Distribution will begin in specialized oncology centers in the coming weeks, with international regulators evaluating approval Source: Excelsior.

Reaction

Experts have called the results "unprecedented" in an area of high unmet need Source: Infobae. Dr. Andrew Hendifar of Cedars-Sinai noted, "This new treatment is astonishingly better than chemotherapy" Source: La Voz. The approval has generated enthusiasm among oncologists and patient groups Source: Diario Libre.