FDA ALERT

FDA Approves Rasonque for Metastatic Pancreatic Adenocarcinoma

Edited by:
Anthony Calabro, MA

Key Highlights

  • The approval applies to adults with metastatic pancreatic adenocarcinoma who received at least 1 prior systemic therapy or are not candidates for multiagent systemic therapy.
  • Daraxonrasib targets multiple forms of RAS, a protein that drives tumor growth in most patients with pancreatic adenocarcinoma.
  • Median overall survival was 13.2 months with daraxonrasib compared with 6.7 months with standard chemotherapy.
  • The oral medication is taken once daily.

On August 26, 2026, the FDA approved daraxonrasib (Rasonque, Revolution Medicines, Inc), a RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multiagent systemic therapy. Daraxonrasib is a once-daily tablet that targets multiple forms of RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma.

The approval was supported by findings from a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma. Daraxonrasib improved median overall survival to 13.2 months compared with 6.7 months among patients who received standard chemotherapy. The FDA granted the therapy Breakthrough Therapy and Orphan Drug designations and Priority Review.

“This drug showed unprecedented results in an area of high unmet need,” Angelo de Claro, MD, director of the FDA’s Oncology Center of Excellence, said in a press release. “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.”

The most common adverse events associated with daraxonrasib are rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

Daraxonrasib is administered orally as a tablet once daily. The FDA release did not specify the recommended dose strength or duration of treatment.

Reference
US Food and Drug Administration. FDA approves first in class targeted therapy for metastatic pancreatic cancer. Published August 26, 2026. Accessed August 26, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-class-targeted-therapy-metastatic-pancreatic-cancer