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The US Food and Drug Administration approved daraxonrasib, sold as Rasonque, on 26 August 2026 for adults with metastatic pancreatic ductal adenocarcinoma.
It is the first broad RAS-targeted medicine cleared for pancreatic cancer - a once-daily oral multi-selective RAS(ON) inhibitor developed by Revolution Medicines of Redwood City, California.
The drug acts on mutated KRAS, an oncogene altered in roughly 90 per cent of pancreatic adenocarcinomas.
In the Phase 3 RASolute 302 trial, median overall survival was 13.2 months against 6.7 months on standard chemotherapy.
The FDA cleared it through its Real-Time Oncology Review pilot, with concurrent review alongside Health Canada under Project Orbis.
RAS genes - of which KRAS is the most frequently mutated in human cancer - produce proteins that act as molecular switches relaying growth signals inside a cell. A mutation can jam the switch in the 'on' position, so the cell keeps dividing. KRAS mutations occur in about 90 per cent of pancreatic adenocarcinomas, which is why the cancer resisted targeted therapy for decades: the RAS protein surface offered no obvious pocket for a drug molecule to bind. Earlier targeted drugs reached only one specific variant, KRAS G12C, in lung cancer. Daraxonrasib is described as multi-selective because it acts on the active, signalling state of the protein across several RAS variants rather than on a single mutation.
Simple Analogy: Older drugs could jam one particular model of faulty switch. This one fits several models of the same switch, and grips it while it is actually switched on.
Regulates drugs, biologics, medical devices and food safety in the United States; runs the RTOR and Project Orbis programmes
India's national drug regulator; approves new drugs and clinical trials
GS Paper III > Science and Technology - developments in biotechnology and health
General Awareness > Science and Current Affairs
General Awareness > Science Current Affairs
General Awareness > Science and Technology Current Affairs
A gene that, when mutated or over-expressed, can drive normal cells to become cancerous. KRAS is among the most commonly mutated in human cancers.
Cancer that has spread from the organ where it began to other parts of the body.
An FDA-coordinated framework under which several national regulators review the same oncology application concurrently, speeding up access across countries.
An FDA pilot programme allowing review of key trial data before the complete application is filed, shortening approval timelines for cancer drugs.
A cancer arising in glandular tissue; pancreatic ductal adenocarcinoma is the most common form of pancreatic cancer.