FDA Approves Rasonque, First RAS-Targeted Cancer Drug

FDA approved Rasonque (daraxonrasib) on 26 August 2026 for previously treated metastatic pancreatic adenocarcinoma, Revolution Medicines' first-in-class RAS inhibitor and the first broad RAS-targeted medicine cleared for the disease — approved nearly seven months ahead of the agency's own review deadline.

Why pancreatic cancer, and why now

Pancreatic ductal adenocarcinoma has been one of oncology's most resistant targets for precision medicine: KRAS mutations drive the large majority of cases, but RAS proteins were considered undruggable for decades because of their smooth surface and high affinity for GTP. Daraxonrasib belongs to a newer class of RAS(ON) inhibitors designed to bind multiple RAS mutant forms — and, in Revolution Medicines' framing, wild-type RAS as well — rather than a single mutation variant, which is why the company and FDA describe it as the first broad RAS-targeted therapy rather than a mutation-specific one.

The trial data

RASolute 302 (NCT06625320) enrolled 500 adults with metastatic pancreatic adenocarcinoma whose disease had progressed after one prior line of systemic therapy, randomizing them evenly to daraxonrasib or investigator's choice of standard chemotherapy. The trial met its primary and key secondary endpoints both in patients with a confirmed tumor RAS G12 mutation and in the broader intent-to-treat population, which included patients without an identified RAS mutation. Median overall survival nearly doubled, from 6.7 months on chemotherapy to 13.2 months on daraxonrasib, a 60% reduction in the risk of death. Patients on daraxonrasib also had a statistically significant delay in time to deterioration of pain and of global health status and quality of life, secondary measures FDA and oncologists weigh alongside survival in advanced-cancer approvals.

A faster review track

Daraxonrasib carried Breakthrough Therapy and Orphan Drug designations before FDA reviewed the application under the Commissioner's National Priority Voucher pilot program, a newer mechanism intended to speed review of therapies addressing national public health priorities. FDA approved the drug roughly 6.5 months ahead of its standard goal date. The label recommends 300 mg of Rasonque orally once daily until disease progression or unacceptable toxicity.