Shots:
- The US FDA has accepted BLA of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma, with no filing review issues identified yet (PDUFA: Apr 14, 2027)
- BLA was backed by the ChonDRAgon study assessing ozekibart vs PBO in pts with metastatic or unresectable conventional chondrosarcoma, which met its 1EP of improved mPFS (5.52 vs 2.66mos.), with a 52% reduction in the risk of disease progression or death
- Ozekibart also demonstrated consistent benefit across all pre-specified subgroups, incl. IDH-wild-type & IDH-mutant tumors, while improving disease control rate (54% vs 27.5%) & delaying deterioration in pain and physical function
Ref: PRnewswire | Image: Inhibrx Biosciences | Press Release
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