The US Food and Drug Administration (FDA) has approved daraxonrasib (Rasonque) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Daraxonrasib is an inhibitor of the RAS GTPase family. Mechanism of Action Daraxonrasib binds to cyclophilin A and forms a complex that binds to the active, GTP-bound state of RAS. This inhibits RAS signaling and promotes conversion to inactive GDP-bound RAS, leading to tumor growth suppression and apoptosis.

Clinical Evidence Supporting Approval The approval was based on the RASolute 302 global, randomized, open-label, multicenter study. A total of 500 patients were randomized to daraxonrasib 300 mg once daily or physician’s choice of standard chemotherapy. Key findings in the overall population included: Median overall survival: 13.2 months vs…