Daraxonrasib approved in the US: Pankind calls for urgent Australian access

On 26 August 2026, the US Food and Drug Administration (FDA) approved RasonqueTM (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one previous systemic therapy, or who are not candidates for multiagent systemic therapy. It is the first broadly targeted RAS inhibitor approved for metastatic pancreatic cancer.

For a disease that has seen far too few major treatment advances, the results behind this approval represent extraordinary progress.

Daraxonrasib's Phase 3 results, nearly doubling median overall survival for those who have previously been treated, represent the first real breakthrough this disease has had, and its FDA approval confirms it as the new standard of care for previously treated metastatic pancreatic cancer.

This is remarkable news for the global pancreatic cancer community. It gives us something this disease has urgently needed: clear evidence that a new approach can meaningfully extend life for some people with advanced pancreatic cancer.

But for Australians, there is still work to do.

What does the FDA approval mean for Australians?

FDA approval means eligible people in the United States can now be prescribed daraxonrasib. Access may still depend on individual insurance coverage and affordability, but there is now an established regulatory pathway for US patients.

The FDA decision does not make daraxonrasib routinely available in Australia.

There is currently no confirmed timeline for Australian regulatory approval or broader access to the treatment. Pankind is seeking clarity on the pathway ahead and is actively engaging with government, the Therapeutic Goods Administration (TGA), clinicians and Revolution Medicines to understand how access can be accelerated for Australians who may benefit.

Pankind will continue advocating for fair and timely access to daraxonrasib and other effective pancreatic cancer treatments. Australians should have the same opportunity to benefit from scientific progress as people elsewhere in the world.

The need is urgent. An estimated 4,825 Australians were diagnosed with pancreatic cancer in 2025. For people living with a disease where treatment options remain limited, every month without a clear pathway to an effective new treatment matters.

A Phase 3 trial is recruiting in Australia

There is also important progress for people who have been newly diagnosed with metastatic pancreatic adenocarcinoma.

A separate Phase 3 clinical trial, RASolute 303, is studying daraxonrasib as a first-line treatment, both on its own and in combination with chemotherapy. The global study is recruiting in Australia, with Australian trial sites listed in the clinical trial registries.

Clinical trials are experimental and have specific eligibility requirements. Anyone interested in the study should speak with their treating clinician about whether participation may be appropriate.

Progress must reach people

Daraxonrasib shows what sustained investment in pancreatic cancer research can achieve. A target once considered extremely difficult to treat has now led to an FDA-approved therapy with a significant survival benefit.

That progress matters. But a breakthrough only reaches its full potential when the people who need it can access it.

We will keep advocating to make pancreatic cancer a fair fight for all Australians.