The FDA reportedly approved Revolution Medicines’ daraxonrasib, to be marketed as Rasonque, on August 26, 2026, for metastatic pancreatic ductal adenocarcinoma (PDAC) after prior treatment, or for patients unable to receive combination chemotherapy.
The once-daily oral drug targets multiple active forms of RAS, a protein pathway that drives tumor growth in many pancreatic cancers.
Approval followed results from the Phase 3 RASolute 302 trial, which reportedly showed daraxonrasib roughly doubled survival compared with standard therapy in advanced pancreatic cancer.
The FDA had previously allowed expanded access for eligible patients with previously treated metastatic PDAC while the application was under review.
The development is considered significant because metastatic pancreatic cancer has historically had limited treatment options and poor survival. The approval’s precise label, safety profile, and commercial price should be confirmed in the FDA’s official prescribing information.
Sources:
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