FDA Approves Rasonque for Metastatic Pancreatic Cancer, Nearly Doubling Survival to 13 Months
Updated
Updated · abcnews.com · Aug 26
FDA Approves Rasonque for Metastatic Pancreatic Cancer, Nearly Doubling Survival to 13 Months
3 articles · Updated · abcnews.com · Aug 26
Summary
Daraxonrasib won FDA clearance for adults with metastatic pancreatic adenocarcinoma after prior systemic therapy, adding a new option in a cancer with historically few effective treatments.
In a 500-patient late-stage trial, the once-daily pill lifted median overall survival to more than 13 months from about 6.7 months with standard chemotherapy by targeting multiple forms of the RAS protein.
The approval follows a June 2025 Breakthrough Therapy designation and an accelerated review under the FDA's National Priority Voucher Program, cutting review time from 12 months to 10 months.
Pancreatic adenocarcinoma makes up about 95% of exocrine pancreatic cancers in the U.S. and, while only 3.2% of cancer diagnoses, accounts for an outsized share of cancer deaths because it is often detected late and progresses aggressively.
With a price tag reaching hundreds of thousands, will this breakthrough pancreatic cancer pill become an inaccessible luxury?
If this drug conquered the most notoriously undruggable cancer mutation, which terminal disease will this revolutionary science cure next?
Could the very mechanism making this molecular clamp so effective also trigger aggressive new forms of cancer resistance?
FDA Approves Daraxonrasib: First RAS Inhibitor Nearly Doubles Survival in Metastatic Pancreatic Cancer
Overview
On August 26, 2026, the FDA approved daraxonrasib (Rasonque) for adults with metastatic pancreatic cancer who had already received treatment. This decision was based on the RASolute 302 trial, which showed that daraxonrasib nearly doubled survival and slowed disease progression compared to chemotherapy. The drug works by forming a stable tricomplex with mutated RAS protein, blocking tumor growth even in dense tumors. Patients benefit from fewer severe side effects, such as less bone marrow toxicity, and proactive care helps manage skin rashes and mouth sores. With this breakthrough, rapid RAS mutation testing and new combination therapies are becoming essential in cancer care.