FDA Accepts Daraxonrasib NDA for Pancreatic Cancer

Key Takeaways

• FDA accepted Revolution Medicines' NDA for daraxonrasib in previously treated metastatic PDAC (announced July 22, 2026).
• RASolute 302 (NCT06625320) compared 300 mg oral daraxonrasib daily with investigator-choice chemotherapy and met primary PFS/OS endpoints in RAS G12–mutant disease plus key secondaries in the ITT set.
• The company said results were presented at ASCO 2026 with simultaneous NEJM publication.
• Daraxonrasib holds Breakthrough Therapy and Orphan Drug designations and was selected for FDA's CNPV pilot.

Daraxonrasib at a glance

Field	Detail
Drug	Daraxonrasib (oral RAS(ON) multi-selective inhibitor)
Company	Revolution Medicines, Inc.
FDA action	NDA accepted for review (announced July 22, 2026)
Proposed use	Previously treated metastatic pancreatic ductal adenocarcinoma
Pivotal trial	RASolute 302 Phase 3 (NCT06625320)
Dose in trial	300 mg orally once daily vs investigator-choice chemo
Designations	Breakthrough Therapy, Orphan Drug; CNPV pilot selection

What did the FDA accept?

Revolution Medicines said the FDA accepted for review an NDA for daraxonrasib in previously treated metastatic PDAC. The product remains investigational until approved. The company positioned it as an oral targeted medicine designed to inhibit RAS signaling across wild-type and mutant RAS(ON) proteins.

See Revolution Medicines' July 22 GlobeNewswire NDA acceptance release.

How was RASolute 302 designed?

RASolute 302 is a global randomized Phase 3 trial of daraxonrasib monotherapy versus investigator's choice among four cytotoxic regimens used as global standards of care. It enrolled patients with metastatic PDAC across RAS G12 variants (including G12D, G12V, and G12R) and patients without an identified tumor RAS mutation.

Primary endpoints were Blinded Independent Central Review PFS (RECIST 1.1) and overall survival in patients with RAS G12–mutant tumors. Secondary endpoints included PFS and OS in the intent-to-treat population. Registration: ClinicalTrials.gov NCT06625320 (RASolute 302).

What efficacy and quality-of-life claims did the company make?

The company said RASolute 302 met all primary and key secondary endpoints, including improvements in overall survival and progression-free survival that it described as unprecedented in this setting. It also said daraxonrasib showed a manageable safety profile and significantly delayed deterioration in cancer-related pain, global health status, and quality of life versus chemotherapy.

• ASCO 2026 presentation with simultaneous New England Journal of Medicine publication (per company)
• EMA CHMP phased review underway; EU orphan and Cancer Medicines Pathfinder high-priority status cited
• Additional Phase 3 program ongoing in PDAC and RAS-mutant NSCLC

How does the CNPV pilot matter here?

Revolution Medicines said daraxonrasib was selected for the FDA Commissioner's National Priority Voucher pilot, which can accelerate collaborative review for priority applications. Program mechanics are described on FDA's CNPV Pilot program page. Breakthrough Therapy and Orphan Drug designations for previously treated metastatic PDAC were also cited.

What remains uncertain?

NDA acceptance is not approval. Exact median OS/PFS numbers, hazard ratios, and grade ≥3 adverse-event rates belong in the ASCO/NEJM primary papers and the FDA review package, not the acceptance wire alone. Label scope—whether limited to RAS G12–mutant disease or broader ITT populations—will be decided at approval. Manufacturing and REMS, if any, are unknown until action.

Related NovaPharma coverage

• Commissioner National Priority Voucher CNPV Pilot
• Revolution Medicines' Daraxonrasib: Pancreatic Cancer Breakthrough
• FDA Approves New Breast Cancer Drug Revtorpyk

Frequently Asked Questions

Primary Sources

1. GlobeNewswire: Revolution Medicines — daraxonrasib NDA acceptance — July 22, 2026
2. ClinicalTrials.gov: RASolute 302 (NCT06625320)
3. FDA: Commissioner's National Priority Voucher (CNPV) Pilot Program