US health authorities have approved Revolution Medicines' Rasonque (daraxonrasib), an oral once-daily RAS(ON) multi-selective non-covalent inhibitor, for adults with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy or unfit for multi-agent chemotherapy, six and a half months ahead of the user-fee deadline under the agency's priority review voucher pathway.

The decision rests on the Phase III RASolute 302 trial (n=500, 1:1 randomisation) where daraxonrasib delivered median overall survival (OS) of 13.2 months versus 6.7 months for investigator-choice chemotherapy (HR 0.40, p<0.0001) in the overall population, with consistent progression-free survival (PFS) and objective response rate (ORR) gains and no new safety signals; the label covers patients regardless of identified RAS mutation status and requires no companion diagnostic.

Pancreatic adenocarcinoma carries a US incidence near 60,000 annually and a five-year survival around 3%, with over 90% of tumours RAS-driven, making daraxonrasib the first targeted medicine in a setting previously confined to cytotoxic chemo.

Revolution positions the asset as the founding member of a RAS(ON) class spanning multi-selective and mutant-selective molecules, with commercial uptake supported by a 300 mg oral tablet profile, an established expanded-access base, and planned registrational work in RAS-mutant NSCLC.