Live News • Jul 25
Revolution Medicines Drug Doubles Survival for Pancreatic Cancer Patients in Trial Data Revolution Medicines reported that its experimental drug daraxonrasib nearly doubled survival for pancreatic cancer patients who had no other treatment options, according to recent clinical trial data.
The company’s progress with daraxonrasib comes as large pharmaceutical groups increasingly license drug candidates from smaller biotechs, with Chinese firms now providing nearly one third of such licensed assets to big pharma.
Revolution Medicines’ stock trades at US$189.23, with the share price up 139.5% year to date, highlighting strong recent momentum in the market’s view of the company.
This kind of survival benefit in a hard-to-treat cancer can influence how potential partners and larger drug companies assess Revolution Medicines, particularly if licensing flows between U.S. and Chinese biotechs face tighter rules. Announcement • Jul 25
U.S. Food and Drug Administration Accepts New Drug Application For Daraxonrasib Accepted For Review A For Previously Treated Metastatic Pancreatic Cancer of Revolution Medicines, Inc Revolution Medicines, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted for review the company's New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The NDA is based on results from the global, randomized Phase 3 RASolute 302 trial, evaluating daraxonrasib versus standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. The trial met all primary and key secondary endpoints, including unprecedented improvements in overall survival and progression-free survival. In addition, daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy. Results from the RASolute 302 trial were presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in The New England Journal of Medicine. Daraxonrasib was selected for the FDA Commissioner's National Priority Voucher pilot program, which is designed to accelerate the review of medicines that address key national health priorities. The FDA previously granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic PDAC. The Company recently announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use has begun a phased review of daraxonrasib, allowing data to be evaluated as they become available before 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 EMA's Cancer Medicines Pathfinder project based on its potential to address a significant unmet need. Daraxonrasib is an investigational, oral RAS(ON) multi-selective, noncovalent tri-complex inhibitor that works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors. It is designed to target cancers driven by a broad range of common RAS genotypes, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer. Daraxonrasib is being advanced through a global Phase 3 registrational program comprising four trials, including the completed RASolute 302 trial and three additional trials in patients with PDAC and metastatic RAS mutant NSCLC. RASolute 302 (NCT06625320) is a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg daraxonrasib once daily or investigator's choice of four different cytotoxic chemotherapy regimens, which represent standard of care across the globe. The trial enrolled patients with metastatic PDAC harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as patients without an identified tumor RAS mutation (wild type). The primary endpoints of the RASolute 302 trial were progression-free survival (PFS), as assessed by a Blinded Independent Central Review according to RECIST 1.1, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints included PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life. 
