India, June 15 -- Inhibrx Biosciences, Inc. (INBX) announced that the U.S. FDA has accepted its BLA for Ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma, a rare and aggressive bone cancer with no approved systemic therapies. The agency reported no filing review issues and assigned a PDUFA action date of April 14, 2027.
Positive Phase 3 Data Supports the Filing
The BLA is backed by results from the study, a randomized, blinded, placebo-controlled, registrational trial that met its primary endpoint of progression-free survival.
Ozekibart reduced the risk of disease progression or death by 52% compared with placebo and more than doubled median PFS to 5.52 months vs. 2.66 months for placebo.If approved, O...