FDA Approves RASONQUE for Metastatic Pancreatic Cancer

The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ RASONQUE (daraxonrasib), a once-daily oral treatment for adults with metastatic pancreatic adenocarcinoma (PDAC).

The approval covers patients whose cancer has progressed after at least one prior systemic treatment, as well as adults who are not candidates for multiagent systemic therapy. RASONQUE is available as a 300 mg once-daily oral tablet and does not require a companion diagnostic test.

According to Revolution Medicines, RASONQUE is the first approved targeted cancer medicine from a new class of RAS(ON) inhibitors designed to target RAS signaling. RAS plays a major role in pancreatic cancer, making it an important target for developing new treatments.

The FDA decision was supported by results from the global Phase 3 RASolute 302 trial, which compared RASONQUE with investigator-selected chemotherapy in patients with previously treated metastatic PDAC.

In the overall trial population, RASONQUE reduced the risk of death by 60% compared with chemotherapy. Median overall survival was 13.2 months for patients receiving RASONQUE, compared with 6.7 months for those receiving chemotherapy.

The treatment also improved progression-free survival. Median progression-free survival was 7.2 months with RASONQUE versus 3.6 months with chemotherapy, representing a 51% reduction in the risk of disease progression or death.

The benefits extended to patient-reported outcomes. Patients treated with RASONQUE experienced a longer period before deterioration in overall health status and quality of life. The median time to deterioration was 5.7 months with RASONQUE compared with 2.6 months with chemotherapy.

RASONQUE also delayed worsening of clinically relevant pain, with a median time to deterioration of 9.2 months compared with 3.8 months for chemotherapy.

The safety profile was described as manageable. Common adverse reactions included rash, diarrhea, stomatitis, nausea, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.

The approval marks an important development in pancreatic cancer treatment, where patients have historically had limited options after initial therapy. Revolution Medicines said the company is continuing discussions with regulatory authorities in other countries to expand access to RASONQUE.

Alongside the U.S. launch, Revolution Medicines has introduced its (ON)Path patient support program. The program is designed to help eligible patients with insurance navigation, financial assistance and treatment education.

With its approval, RASONQUE provides physicians with a new oral targeted treatment option for adults with metastatic pancreatic adenocarcinoma and represents a new approach to targeting RAS-driven cancer.