Inhibrx BLA Acceptance Sets PDUFA April 2027 after Ozekibart Cuts Progression Risk 52%
INBX•FDA accepted Inhibrx’s BLA for ozekibart for unresectable or metastatic conventional chondrosarcoma, with a PDUFA goal date of April 14, 2027. The ChonDRAgon trial showed ozekibart halved progression risk (HR 0.479; P<0.0001) and more than doubled median PFS to 5.52 vs 2.66 months.
1. FDA Acceptance of BLA
The FDA has accepted Inhibrx’s BLA for ozekibart for unresectable or metastatic conventional chondrosarcoma, assigning a PDUFA goal date of April 14, 2027. No filing review issues were identified, marking a critical regulatory milestone toward potential approval.
2. Positive Phase III Efficacy Data
In the ChonDRAgon registrational trial of 206 patients, ozekibart reduced the risk of disease progression or death by 52% (HR 0.479; 95% CI 0.33–0.68; P<0.0001). Median progression-free survival more than doubled to 5.52 months versus 2.66 months with placebo.
3. Manageable Safety Profile
Ozekibart was generally well tolerated, with fatigue, constipation and nausea as the most common adverse events. Early hepatotoxicity risk was mitigated by excluding patients with severe liver impairment and implementing close monitoring, resulting in a low incidence of hepatic events.
4. Commercial and Development Outlook
If approved, ozekibart would be the first FDA-approved therapy for unresectable or metastatic conventional chondrosarcoma and Inhibrx’s first commercial product. Ongoing expansion cohorts are evaluating ozekibart in Ewing sarcoma and colorectal cancer combinations, supporting broader development potential.
