FDA Approves Daraxonrasib, Marking Milestone in Metastatic Pancreatic Cancer Treatment

　　On August 26,2026,the U.S.FDA completed its review 6.5 months ahead of schedule,approving daraxonrasib(brand name:Rasonque),a RAS-GTPase family inhibitor,for the treatment of adult patients with metastatic pancreatic cancer.Granted Breakthrough Therapy and Orphan Drug designations,and facilitated by the Orbis and RTOR programs,this approval provides a novel oral targeted option for a disease with historically poor prognosis.

　　Product Profile and Indications

　　Developed by Revolution Medicines,Inc.,daraxonrasib is an oral RAS(ON)multi-selective inhibitor targeting high-frequency RAS mutation pathways in pancreatic cancer.It is administered orally at a recommended dose of 300mg once daily,eliminating the need for hospital infusion.The review included Health Canada,with the EMA and Japan's PMDA as observers,paving the way for global expansion.

　　The approved indications cover two groups:patients with disease progression after at least one systemic therapy,and those unfit for multi-drug combination chemotherapy.Notably,it is not restricted to RAS G12 mutations,benefiting the overall patient population.

　　Clinical Efficacy

　　The approval was based on the Phase 3 RASolute 302 trial(n=500).The drug arm achieved a median OS of 13.2 months versus 6.7 months for chemotherapy(HR=0.40),reducing the risk of death by 60%.Median PFS was 7.2 months versus 3.6 months(HR=0.49),and the ORR was 30%versus 11%.All primary endpoints were met with statistical significance.

　　Safety and Clinical Impact

　　The label includes warnings for dermatologic toxicity,stomatitis,diarrhea,gastrointestinal perforation,and interstitial lung disease.Its approval proves that pan-RAS inhibition is viable,breaking the"undruggable"barrier and shifting the paradigm away from sole reliance on chemotherapy for late-stage pancreatic cancer.