Revolution Medicines, which is developing targeted therapies for RAS-addicted cancers, has received one of the first U.S. Food and Drug Administration (FDA) non-transferrable vouchers under the new Commissioner’s National Priority Voucher (CNPV) pilot program. The voucher, aimed at accelerating approval time dramatically, is for daraxonrasib (RMC-6236), Revolution’s oral, direct RAS(ON), multi-selective inhibitor.
RAS has been amongst the most notoriously undruggable targets in cancer. Revolution says its tri-complex platform enables direct inhibition of the active, ON state of RAS driving formation of a novel tri-complex and blocking oncogenic signaling.
“We are honored to receive one of the first vouchers awarded under the Commissioner’s National Priority Voucher pilot program. As with the Breakthrough Therapy Designation daraxonrasib received earlier this year, we believe this voucher recognizes the large unmet need for new treatments for patients with RAS-addicted cancers and the potential of the investigational drug daraxonrasib to transform treatment for these diseases, including pancreatic cancer,” said Mark A. Goldsmith, MD, PhD, chief executive officer and chairman of Revolution Medicines.
Daraxonrasib is being studied in two global Phase III clinical trials, RASolute 302 in patients with previously treated metastatic pancreatic ductal adenocarcinoma and RASolve 301 in patients with previously treated metastatic non-small cell lung cancer.
Goldsmith added, “With an expected data readout from RASolute 302 in 2026, we look forward to participating in the CNPV program and working with the FDA to bring daraxonrasib to patients.”
The FDA’s CNPV pilot program has the goal of accelerating the development and review of certain drugs and biological products that are “aligned with U.S. national health priorities and enhancing the health interests of Americans.” The program aims to offer an “unprecedented opportunity to reduce drug and biological product application or efficacy supplement (ES) review times from 10-12 months to just 1-2 months.” Announced in June 2025, the program uses a collaborative tumor board style review process to accelerate approvals for companies aligned with “critical U.S. national health priorities.”
Companies selected for the program are issued a voucher entitling them to benefits including enhanced communications and rolling review to allow for a shortened review time.
Revolution is evaluating the impact of the voucher and says it is not adjusting any of its previously disclosed timelines at this time.
The company says daraxonrasib has the potential to help address a wide range of cancers driven by oncogenic RAS mutations. The drug suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X, which are common drivers of major cancers, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer.
Revolution is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. RAS(ON) inhibitors it has in clinical development include daraxonrasib; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development.
