FDA Accepts Inhibrx Biologics License Application for Ozekibart

If approved, the drug would become the first systemic therapy available for patients with this rare and aggressive bone cancer. The Biologics License Application rests on data from the ChonDRAgon study, a randomized, blinded, placebo-controlled trial that enrolled 206 patients. Results showed that ozekibart reduced the risk of disease progression or death by 52% compared to a placebo. Participants receiving the therapy saw their median progression-free survival more than double, reaching 5.52 months against 2.66 months in the control group.

Mark Lappe, Chief Executive Officer of Inhibrx, described the acceptance as a monumental milestone for the company and the chondrosarcoma community. Chondrosarcoma currently lacks any approved systemic treatment options, leaving surgical resection as the primary management strategy for localized cases. Ozekibart, a tetravalent death receptor 5 agonist antibody, has previously received Fast Track and orphan drug designations from the FDA. While the trial noted some instances of hepatotoxicity, the company implemented monitoring protocols that successfully mitigated the risk during the study.