On July 22, 2026, Revolution Medicines announced that the US Food and Drug Administration had accepted for review the company’s New Drug Application for daraxonrasib for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma.
Daraxonrasib is an investigational oral RAS(ON) multi-selective inhibitor.
Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, said:
“The FDA’s acceptance of the daraxonrasib NDA is an important step in the regulatory review process and brings us closer to the possibility of offering patients a new targeted medicine for previously treated metastatic pancreatic cancer.”
“Daraxonrasib is an oral targeted medicine designed to inhibit RAS, the main cause of pancreatic cancer, and the application is supported by unprecedented results from the Phase 3 RASolute 302 trial. These findings underscore the potential for daraxonrasib to become a new standard of care and to help define a new class of RAS‑targeted medicines for this disease. We look forward to continuing to work closely with the FDA as the agency reviews the application, and with other global regulatory authorities as we advance our efforts to bring daraxonrasib to patients as quickly as possible.”
What is Daraxonrasib
Daraxonrasib is an investigational, oral, RAS(ON) multi-selective, noncovalent tri-complex inhibitor. It works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.
Daraxonrasib is designed to target cancers driven by a broad range of common RAS genotypes, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer.
The global phase 3 registrational program includes the completed RASolute 302 trial and three additional trials in patients with pancreatic ductal adenocarcinoma and metastatic RAS-mutated non-small cell lung cancer.
RASolute 302 Study Design
RASolute 302, NCT06625320, is a global, randomized, registrational phase 3 trial designed to evaluate the efficacy and safety of daraxonrasib monotherapy in patients with previously treated mPDAC.
Patients were randomly assigned to receive daraxonrasib at an oral dose of 300 mg once daily or the investigator’s choice of four cytotoxic chemotherapy regimens representing standards of care used globally.
The study enrolled patients with metastatic pancreatic ductal adenocarcinoma harboring a range of RAS variants, including RAS G12D, G12V, and G12R mutations. Patients without an identified tumor RAS mutation were also included.
The primary endpoints were progression-free survival by blinded independent central review according to RECIST 1.1 and overall survival, both evaluated in patients with RAS G12-mutated tumors.
Secondary endpoints included progression-free and overall survival in the intention-to-treat population, as well as objective response rate, duration of response, and patient-reported quality of life.
Phase 3 RASolute 302 Trial Results
The NDA is based on results from the global, randomized phase 3 RASolute 302 trial. Detailed findings were presented by Brian M. Wolpin, MD, MPH, during the ASCO 2026 Plenary Session and simultaneously published in The New England Journal of Medicine.
The trial enrolled 500 patients with previously treated metastatic pancreatic ductal adenocarcinoma. Patients were randomly assigned to receive daraxonrasib 300 mg orally once daily or investigator’s choice of standard cytotoxic chemotherapy. The study included patients with and without an identified tumor RAS mutation.
In the RAS G12 population, median overall survival was 13.2 months with daraxonrasib versus 6.6 months with chemotherapy (HR, 0.40). Median progression-free survival was 7.3 versus 3.5 months, respectively (HR, 0.45).
In the overall population, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy (HR, 0.40), while median progression-free survival was 7.2 versus 3.6 months (HR, 0.49). The confirmed objective response rate was 31.6% versus 11.2%, respectively.
Grade 3 or higher treatment-related adverse events occurred in 43.6% of patients receiving daraxonrasib and 57.5% of those receiving chemotherapy. Treatment-related adverse events led to treatment discontinuation in 1.2% and 11.2% of patients, respectively. Daraxonrasib also significantly delayed time to deterioration in pain and global health status/quality of life compared with chemotherapy.
FDA and EMA Regulatory Programs
Daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review of medicines addressing key national health priorities.
The FDA had previously granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma.
Revolution Medicines also recently announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use had begun a phased review of daraxonrasib. The phased review allows data to be evaluated as they become available before the submission of a full marketing authorization application.
Daraxonrasib has also received orphan medicine designation for the treatment of pancreatic cancer and high-priority status under the EMA Cancer Medicines Pathfinder project.
The full announcement is available on the Revolution Medicines website.
Find more videos on OncoDaily YouTube TV.