Inhibrx Biosciences Inc (Nasdaq: INBX) disclosed on Monday that it has received U.S. Food and Drug Administration acceptance of its Biologics License Application for ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma, with a Prescription Drug User Fee Act target action date of 14 April 2027.

No filing review issues were identified by the FDA. If approved, ozekibart would become the first FDA-approved systemic therapy for the rare bone cancer and Inhibrx's first commercial product.

This application is supported by results from the Phase III ChonDRAgon trial, which enrolled 206 patients globally and met its primary endpoint. Ozekibart reduced the risk of disease progression or death by 52% versus placebo and more than doubled median progression-free survival to 5.52 months from 2.66 months.

The treatment also demonstrated improvements in disease control rate and delayed deterioration in pain and physical function. Benefits were observed across all pre-specified patient subgroups, including those with IDH-wild-type and IDH-mutant tumours.

Ozekibart was generally well tolerated, with fatigue, constipation and nausea among the most common treatment-related adverse events. Hepatic safety risks were managed through patient selection criteria and enhanced monitoring measures implemented during the study.

The drug previously received FDA Fast Track designation in January 2021 and Orphan Drug designation in November 2021 for chondrosarcoma. Inhibrx is also evaluating ozekibart in combination therapies for Ewing sarcoma and colorectal cancer.