Revolution Medicines (RVMD) announced that the FDA has accepted its regulatory filing for approval of daraxonrasib, a treatment for previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The application is being reviewed under the FDA’s Commissioner’s National Priority Voucher pilot program, which aims to expedite the review process for drugs targeting high unmet medical needs, potentially reducing the review timeline to about six months.
The filing is underpinned by results from the phase III RASolute 302 study, where daraxonrasib demonstrated a 60% reduction in the risk of death compared to chemotherapy and nearly doubled median overall survival. If approved, it would be Revolution Medicines’ first marketed product, marking a significant transition to a commercial-stage company.
Year-to-date, Revolution Medicines’ stock has surged by 130%, starkly contrasting with the industry average growth of just 2%. Daraxonrasib is also being evaluated in multiple settings for RAS-driven cancers, with additional trials ongoing for non-small cell lung cancer and other forms of PDAC.
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