FDA Approves Revolution Medicines' Rasonque (Daraxonrasib) as First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer
On August 26, 2026, the U.S. Food and Drug Administration (FDA) approved Rasonque (daraxonrasib), developed by Revolution Medicines, Inc., as a once-daily oral tablet for the treatment of adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. This landmark decision introduces the first approved targeted cancer medicine from a new class of RAS(ON) multi-selective and mutant-selective inhibitors, directly addressing a protein that has historically been considered one of the most intractable disease targets in oncology.
The FDA approved Rasonque for patients with or without an identified RAS tumor mutation, eliminating the need for a companion diagnostic test. The approval was granted 6.5 months ahead of the user fee deadline under the Commissioner's National Priority Voucher (CNPV) pilot program.
Unprecedented Survival Benefits in RASolute 302
The regulatory approval is supported by robust data from the global, randomized Phase 3 RASolute 302 trial, which evaluated Rasonque (300 mg once daily) against investigator's choice of cytotoxic chemotherapy in 500 adults with previously treated metastatic PDAC:
- Overall Survival (OS): Rasonque nearly doubled overall survival, improving median OS to 13.2 months compared to 6.7 months for standard chemotherapy.
- Tolerability: The therapy demonstrated a manageable safety profile, with common side effects including rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
Key Executive Perspectives
Acting FDA Commissioner Kyle Diamantas emphasized the agency's focus on accelerating high-impact therapies:
"Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible. I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality."
Dr. Angelo de Claro, director of the FDA’s Oncology Center of Excellence, commented on the speed of the review:
"This drug showed unprecedented results in an area of high unmet need. The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions."
Dr. Mark A. Goldsmith, Chief Executive Officer of Revolution Medicines, highlighted the broader implications for the RAS(ON) platform:
"The FDA approval of RASONQUE is a monumental step forward for patients with pancreatic cancer and for the oncology field. For the first time, patients have an approved targeted medicine designed to directly inhibit the main cause of pancreatic cancer, RAS, which has been one of the most intractable disease targets since its discovery decades ago."