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FDA接受ozeikibart的Inhibrx BLA
2026-06-15 22:34
- The US FDA has accepted for review Inhibrx Biosciences' (INBX) BLA for ozekibart to treat unresectable or metastatic conventional chondrosarcoma.
- The application has an action date of April 14, 2027.
- There are currently no FDA-approved therapies for the rare bone cancer.
- The BLA is supported by data from the ChonDRAgon study that met its primary endpoint of a statistically significant median progression-free survival for individuals given ozekibart compared to placebo.
- Ozekibart is considered a tetravalent death receptor 5 (DR5) agonist antibody.
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