FDA Grants Approval to Novel Pancreatic Cancer Drug Daraxonrasib

The FDA has approved a pancreatic cancer therapy that, in clinical studies, almost doubled patients’ overall survival.

The medication, daraxonrasib—marketed as Rasonque by Revolution Medicines—represents a significant advance against one of the most lethal cancers.

In a late‑stage trial involving 500 participants, patients receiving the daily tablet lived a median of 13.2 months, versus 6.6 months for those receiving standard chemotherapy.

The FDA described the drug as a “critical new option for patients confronting an exceptionally challenging, historically intractable cancer.”

Daraxonrasib works by binding to and inhibiting the mutated KRAS gene, present in over 90 % of pancreatic tumors and a key driver of their growth.

Approximately 67,000 Americans receive a pancreatic cancer diagnosis annually; the disease carries the highest mortality rate among major cancers, per the American Cancer Society.

Pancreatic cancer is frequently detected at an advanced stage and remains notoriously tough to treat, with more than half of patients succumbing within three months of diagnosis.

In 2025 the FDA awarded daraxonrasib a Breakthrough Therapy designation, reserved for therapies addressing serious conditions that merit accelerated review.

The agency approved the drug six months before the statutory deadline, citing “unprecedented results in an area of high unmet need,” according to Angelo de Claro, director of the FDA’s Oncology Center of Excellence.

The most frequent adverse events were rash, diarrhea, nausea, fatigue, and vomiting, the FDA reported. Severe side effects occurred in roughly 44 % of daraxonrasib recipients, versus 57.5 % of those receiving chemotherapy in the trial.

Former U.S. Senator Ben Sasse, who disclosed a Stage 4 pancreatic cancer diagnosis last December, is enrolled in a clinical trial of the drug and reports that it has helped reduce his tumor burden.

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