Revolution Medicines' NDA for Daraxonrasib Accepted for FDA Review in Metastatic Pancreatic Cancer
Thursday, July 23, 2026
Revolution Medicines has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for daraxonrasib, an investigational oral RAS(ON) multi-selective inhibitor, for the treatment of previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
The NDA is supported by results from the global Phase 3 RASolute 302 clinical trial, which compared daraxonrasib with standard-of-care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, regardless of whether a tumour RAS mutation had been identified.
According to the company, the trial met all primary and key secondary endpoints, demonstrating improvements in overall survival and progression-free survival. The study also showed a manageable safety profile, while patients receiving daraxonrasib experienced a slower decline in cancer-related pain, overall health status and quality of life compared with those treated with chemotherapy.
Results from the RASolute 302 trial were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine.
The FDA selected the application for its Commissioner's National Priority Voucher pilot programme, which is intended to accelerate the review of medicines addressing significant national health priorities. Daraxonrasib has also received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for previously treated metastatic PDAC.
In Europe, the European Medicines Agency (EMA) has begun a phased review of daraxonrasib, allowing clinical data to be assessed before the submission of a full Marketing Authorisation Application. The investigational therapy has also received orphan medicine designation for pancreatic cancer and has been granted high-priority status under the EMA's Cancer Medicines Pathfinder programme.
The FDA's review represents a further step towards potential regulatory approval of daraxonrasib as a targeted treatment option for patients with previously treated metastatic pancreatic cancer.
Source: globenewswire.com
