FDA Approves Daraxonrasib (Rasonque) for Advanced Pancreatic Cancer

The FDA has approved daraxonrasib, now sold under the brand name Rasonque, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-drug chemotherapy. It is a once-daily oral targeted therapy that blocks RAS proteins, which are abnormally active in more than 90% of pancreatic cancers. RAS was long considered "undruggable," and this is the first broadly effective RAS-targeting therapy approved for this disease.

The approval is based on the Phase 3 RASolute 302 trial, in which patients with previously treated advanced pancreatic cancer lived a median of 13.2 months on daraxonrasib, compared with 6.7 months on standard chemotherapy. Patients on daraxonrasib also reported better quality of life and improved pain control.

The most common side effects were rash, mouth sores, and diarrhea. These are usually managed by pausing or lowering the dose, and very few patients in the trial needed to stop treatment because of side effects.

The drug was approved regardless of a tumor's specific RAS mutation, but biomarker testing is still recommended for all patients with pancreatic cancer, since it can point to other treatment options and clinical trials. Patients who were receiving daraxonrasib through the expanded access program will move to commercial supply through their insurance. Trials are continuing to test the drug in combination with chemotherapy and after surgery to help prevent recurrence.

We're sharing this update because developments like this can be meaningful for patients and families navigating a pancreatic cancer diagnosis. As always, treatment decisions should be made with your care team based on your specific diagnosis and health history.

Read the full article from the Pancreatic Cancer Action Network: FDA Approves RASONQUE™ (daraxonrasib)