The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Juniper Biosciences' PET tracer JBS-003 (F-18 fluoromisonidazole, or FMISO) for identifying tumor hypoxia to guide de-escalated radiation therapy in patients with HPV-positive oropharyngeal carcinoma (OPC).
JBS-003, licensed from Memorial Sloan Kettering Cancer Center, identifies tumor hypoxia, a marker of radioresistance, and enables clinicians to risk-stratify patients, Juniper said. Approximately 80% of HPV-positive OPC patients have non-hypoxic tumors that may be eligible for a radiation dose reduction from the standard 70 Gray to 30 Gray, according to the company.
The designation is supported by clinical evidence from investigator-led studies at Memorial Sloan Kettering and an ongoing phase III trial expected to reach primary completion in early 2028, Juniper noted.
