US FDA Approves Drug That Could Extend Survival In Metastatic Pancreatic Cancer

The US Food and Drug Administration (FDA) on Wednesday approved daraxonrasib (Rasonque), an oral RAS inhibitor that could extend survival for adults with metastatic pancreatic cancer who have previously received at least one systemic treatment or are not candidates for multiagent systemic therapy.

The approval marks the first targeted therapy approved for metastatic pancreatic adenocarcinoma, offering a new treatment option for patients with a cancer that has historically been difficult to treat.

Drug targets RAS proteins driving tumour growth

Daraxonrasib is taken as a once-daily tablet and targets multiple forms of RAS, a protein involved in driving tumour growth in pancreatic adenocarcinoma.

Pancreatic adenocarcinoma accounts for around 90% to 95% of pancreatic cancer cases, according to the National Cancer Institute. The disease is often diagnosed at an advanced stage and can progress rapidly, contributing to its high mortality.

Trial shows survival benefit

The FDA approval was based on a randomized, open-label, multicenter trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma.

Patients who received daraxonrasib had a median overall survival of 13.2 months, compared with 6.7 months for those who received standard chemotherapy.

Data from the Phase 3 RASolute 302 trial similarly showed a substantial survival benefit among patients with a RAS G12 mutation, including a 60% reduction in the risk of death.

The trial also found that progression-free survival was nearly doubled. Median PFS was 7.3 months among patients with RAS G12 mutations and 7.2 months across the overall cohort, compared with 3.5 and 3.6 months, respectively, for chemotherapy.

The drug also demonstrated a more tolerable safety profile compared with chemotherapy in the trial.

New option for difficult-to-treat cancer

FDA officials described the approval as an important new option for patients facing an aggressive cancer with a significant unmet treatment need.

The approval came 6.5 months ahead of the drug's user fee deadline, according to the information provided.

Daraxonrasib's approval represents a significant development in efforts to target RAS-driven cancers and provides patients with metastatic pancreatic adenocarcinoma another treatment option after earlier systemic therapy.

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