FDA approves first-in-class therapy for metastatic pancreatic cancer

The FDA has approved Rasonque (daraxonrasib), a first-in-class targeted therapy for metastatic pancreatic cancer, more than six months ahead of its PDUFA date.

Pancreatic cancer often presents in the later stages because of a lack of early symptoms. This year, there will be an estimated 67,530 new cases of pancreatic cancer and about 52,740 deaths from this cancer, according to the National Cancer Institute’s Surveillance, Epidemiology and End Results Program (SEER). Overall, the five-year survival rate for pancreatic cancer is 13.7%. Early diagnosis before the cancer has spread increases the survival rate to 43.6%.

Developed by Revolution Medicines, Rasonque is a once-daily tablet that targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma. Rasonque works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins.

Rasonque was approved through the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review of medicines that address key national health priorities.

The approval was based on data from the phase 3 RASolute 302 study, an open-label clinical trial that enrolled 500 adults with previously treated metastatic pancreatic adenocarcinoma.

The trial met all primary and key secondary endpoints, including unprecedented improvements in overall survival and progression-free survival. Rasonque improved median overall survival to 13.2 months compared with 6.7 months for standard chemotherapy. The difference in progression-free survival was similar: a median of 7.3 months in the daraxonrasib group compared with 3.5 months in the chemotherapy group.

The most common side effects of the drug are rash, diarrhea, stomatitis (inflammation of the mouth’s mucus membranes), nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. Treatment-related adverse events that led to treatment discontinuation occurred in 1.2% of the patients in the daraxonrasib group and in 11.2% of those in the chemotherapy group.

Related: Pashtoon Kasi, M.D., on daraxonrasib's impact on patients: 'You have to see it to believe it' | ASCO 2026

Data from the RASolute 302 trial were presented in May 2026 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and published in The New England Journal of Medicine on May 31, 2026.