Today daraxonrasib, an oral RAS(ON) multi-selective inhibitor from Revolution Medicines, was approved by the FDA for use by patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) or for patients who are “not candidates for multiagent systemic therapy.” This approval was supported by the remarkable results from the Phase 3 clinical trial, RASolute 302, that demonstrated an unprecedented increase in overall survival (OS), increases in progression-free survival (PFS), and a differentiated safety profile compared with standard of care chemotherapy. This also is the first RAS inhibitor to be approved by the FDA for cancer therapy and will be sold under the name Rasonque.
This approval comes just over 1 month after Revolution Medicine’s New Drug Application (NDA) for daraxonrasib was accepted for review by the FDA, on July 22, 2026, capping off daraxonrasib’s whirlwind clinical development.
The initial first-in-human Phase 1/2 clinical trial, RMC-6236-001, started in June 2022 in patients with advanced solid tumors harboring RAS mutations. A phase 3 trial for previously treated metastatic PDAC patients, RASolute 302, began just over 2 years later in October 2024 based on the clear benefit and safety outcomes in the PDAC patients from that original trial.
On June 23, 2025, the FDA granted daraxonrasib Breakthrough Therapy Designation for treating patients with metastatic PDAC based on the promising results from the RMC-6236-001 trial. This designation allows the acceleration of the development and subsequent review of new therapies that treat diseases that have significant unmet needs. Daraxonrasib was awarded this designation, because of the early clinical evidence that demonstrated improvement in metastatic PDAC over other currently available therapies.
Additionally, on October 16, 2025, Revolution Medicines was awarded one of the first vouchers under FDA Commissioner’s National Priority Voucher Pilot Program for daraxonrasib. This program’s goal is to accelerate the development and subsequent review of therapies aligned with US health priorities with the goal of enhancing Americans’ health interests. This program allows approval data to be reviewed on a rolling basis as available, potentially cutting down FDA review of NDAs from 10-12 months to as quick as 30-90 days.
These events culminated in the announcement in April 2026 of the completion of the phase 3 RASolute 302 clinical trial touting unprecedented doubling of median overall survival over standard of care chemotherapies. Initial data was submitted to the FDA on April 28th, 2026 for approval for an Expanded Access Program (EAP) to provide daraxonrasib to previously treated, metastatic PDAC patients outside of a clinical trial setting and was granted by the FDA on May 1, 2026. Through the EAP Revolution Medicines has been able to supply more than 2,000 additional patients with daraxonrasib over the last 3 months.
The full data set was presented to a standing ovation on May 31, 2026 at the American Society for Clinical Oncologists Annual Meeting and concurrently published in the New England Journal of Medicine leading up to the accepted submission of the NDA on July 22, 2026.
While an approval of daraxonrasib for previously treated metastatic PDAC is exciting news, there are newly launched phase 3 clinical trials evaluating daraxonrasib in other PDAC patient populations; RASolute 303 (NCT07491445) in previously untreated patients with metastatic PDAC alone or in combination with chemotherapy and RASolute 304 (NCT07252232) in patients with resected PDAC following adjuvant chemotherapy treatment. Additionally, there are early-stage clinical trials evaluating the use of daraxonrasib with other targeted therapies including mutant specific RAS inhibitors. The results from these trials have the potential to expand approvals for daraxonrasib to more patient populations allowing many more patients to benefit from this emerging and potentially transformational therapy.
Discoveries like daraxonrasib are only possible because scientists were given the resources to pursue questions long before the answers were in sight. Without early-stage funding for bold ideas none of this would be possible. Now, more than ever, new treatment options, early detection, and hope for better outcomes is on the horizon.
