Revolution Medicines' Daraxonrasib Nears FDA Filing and Enters Accelerated Phased Review in Europe
On July 7, 2026, Revolution Medicines announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has initiated a phased review for its investigational, oral RAS(ON) multi-selective inhibitor, daraxonrasib (RMC-6236), for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). This regulatory milestone occurs as the company is nearing the completion of its rolling New Drug Application (NDA) submission to the U.S. FDA under the agency's Commissioner’s National Priority Voucher pilot program.
Pancreatic cancer is notoriously aggressive, typically diagnosed at an advanced or metastatic stage in 80% of patients and carrying a 5-year survival rate of just 3%. The EMA’s phased review process evaluates clinical data in phases as they become available, accelerating the timeline before a full marketing authorization application is formally submitted. The drug has also been recognized under the EMA's Cancer Medicines Pathfinder project and designated as an orphan medicinal product.
Pivotal Phase 3 RASolute 302 Efficacy
The regulatory momentum is supported by unprecedented survival data from the Phase 3 RASolute 302 trial (NCT06625320), which evaluated daraxonrasib monotherapy (300 mg once daily) against investigator's choice of standard cytotoxic chemotherapy in approximately 500 adult patients with previously treated metastatic PDAC harboring codon 12, 13, or 61 RAS mutations:
- Survival Double: Daraxonrasib nearly doubled median overall survival (OS) to 13.2 months compared to 6.7 months for the chemotherapy arm (Hazard Ratio [HR] of 0.40, P < 0.0001).
- Clinical Benefit & Tolerability: Updated data presented at the 2026 ASCO Annual Meeting showed a manageable safety profile, alongside a statistically significant delay in the deterioration of cancer-related pain, global health status, and quality of life.
Combination Pipeline Progress
Beyond monotherapy, early combination data released in June 2025 pairing daraxonrasib with Tango Therapeutics' PRMT5 inhibitor vopimetostat in a Phase 1/2 trial (NCT06922591) for MTAP-deleted and RAS-mutant metastatic PDAC demonstrated a staggering 92% objective response rate (ORR) (11 of 12 patients) and a 100% disease control rate, prompting plans to advance the combination into Phase 3 development for first-line patients.