FDA approves Revolution Medicines’ Rasonque, marking a major advance in KRAS/RAS-targeted pancreatic-cancer treatment

On August 26, 2026, the U.S. FDA approved Revolution Medicines’ Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic treatment or are not candidates for multiagent therapy.

The once-daily 300 mg pill is the first approved broad RAS-targeted medicine in this setting. It inhibits the active “RAS(ON)” protein across multiple RAS variants, potentially addressing cancers that previously lacked effective targeted options.

In the Phase 3 RASolute 302 trial, median overall survival was 13.2 months with Rasonque versus 6.7 months with standard chemotherapy. The company reported a 60% reduction in the risk of death, along with improvements in progression-free survival and response rates.

The approval does not require a companion diagnostic and applies whether or not a patient’s tumor has an identified RAS mutation, according to the FDA and company announcement.

Rasonque is now available by prescription in the United States. Revolution listed the price at $39,800 for a 30-day supply before insurance coverage, discounts, or assistance.

The decision is being viewed as a milestone for KRAS/RAS drug development. Researchers hope the same therapeutic approach can eventually expand into other RAS-driven cancers, including lung and colorectal cancers, though further trials are needed.