FDA Grants Breakthrough Therapy Designation to JBS-003 for Guiding Radiation Therapy in HPV-Positive Head and Neck Cancer

Juniper Biosciences announced that the FDA has granted Breakthrough Therapy Designation to JBS-003 (18F-fluoromisonidazole, or FMISO). This first-in-class hypoxia tracer aims to identify tumor hypoxia to guide de-escalated radiation therapy in patients with HPV-positive Oropharyngeal Carcinoma (OPC), potentially sparing them from severe side effects of high-dose radiation.