Daraxonrasib Cuts Death Risk 60%, Prompts Rolling NDA Submission for Pancreatic Cancer
RVMD•Revolution Medicines' Daraxonrasib cut death risk by 60% and extended median survival to 13.2 months versus 6.7 months in a 500-patient Phase 3 pancreatic cancer trial. The company is advancing a rolling NDA submission with plans to pursue global approvals and expanded patient access programs.
1. Phase 3 Trial Results
The 500-patient global RASolute 302 trial tested once-daily Daraxonrasib against standard chemotherapy in previously treated metastatic pancreatic cancer. Daraxonrasib reduced death risk by 60% and extended median overall survival to 13.2 months versus 6.7 months, while improving pain control and quality of life.
2. Regulatory Strategy
Revolution Medicines is submitting a rolling New Drug Application to FDA under a National Priority Voucher and plans to pursue regulatory approvals in multiple countries. The FDA also approved an expanded access program, enabling eligible patients to receive Daraxonrasib before formal marketing authorization.
3. Market Reaction
Shares of Revolution Medicines surged 20% in pre-market trading and gained over 9% in May following the Phase 3 data release. Investors responded to the unprecedented survival data and clear regulatory pathway for the company’s lead oncology candidate.
