FDA approves daraxonrasib, doubling survival in metastatic pancreatic cancer

September 6, 2026 at 01:20 PM2 min

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The U.S. Food and Drug Administration approved daraxonrasib, a new KRAS-targeting drug for metastatic pancreatic cancer, after a 35-day priority review. In the Phase 3 RASolute 302 trial, the drug extended median overall survival to over 13 months, compared with under 7 months for standard chemotherapy. The approval covers previously treated adult patients, and the drug is currently available only in the United States.

Key Facts

The FDA approved daraxonrasib 35 days after the application was submitted under priority review.
In the Phase 3 RASolute 302 trial of 500 previously treated patients, daraxonrasib achieved a median overall survival of over 13 months, versus under 7 months for standard chemotherapy.
Daraxonrasib is a RAS(ON) multi-selective inhibitor that targets all active RAS proteins, unlike earlier drugs that targeted only a single KRAS mutation.
The approval covers adult patients with metastatic pancreatic cancer who have received at least one prior systemic therapy.
The drug is currently available only in the United States; regulatory and reimbursement procedures are pending in Turkey.

KRAS Targeting Breakthrough

KRAS, a mutated protein present in nearly all pancreatic cancer cases, was long considered undruggable because of its smooth surface. University of California scientist Kevan Shokat's foundational discovery enabled the development of molecules that lock KRAS in an inactive state. Daraxonrasib, taken as two pills daily, binds molecules together to disable the KRAS protein. Unlike classical drugs that target only one KRAS mutation, daraxonrasib is a RAS(ON) multi-selective inhibitor that targets all active RAS proteins.

Clinical Trial Results

The Phase 3 RASolute 302 trial enrolled 500 patients who had received at least one prior systemic therapy. Patients receiving daraxonrasib had a median overall survival of over 13 months, compared with under 7 months for those on standard chemotherapy. The survival benefit represents a doubling of life expectancy for this patient population.

Availability and Next Steps

The current FDA approval covers previously treated adult patients with metastatic pancreatic cancer. The drug is available only in the United States, and regulatory and reimbursement procedures in Turkey are still pending. Ongoing research is evaluating daraxonrasib in the first-line setting and in other cancer types such as lung and colorectal cancers.