FDA Grants Breakthrough Therapy Designation to JBS-003 for Guiding De-escalated Radiotherapy in HPV-Positive Oropharyngeal Cancer
On September 1, Juniper Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its hypoxia tracer JBS-003. The product, 18F-Fluoromisonidazole (FMISO), is intended to identify tumor hypoxia and guide de-escalated radiotherapy in patients with HPV-positive oropharyngeal cancer (OPC). JBS-003 is licensed from Memorial Sloan Kettering Cancer Center (MSK). According to information released by the company, the tracer is based on F-MISO PET molecular imaging technology and can visualize specific hypoxic features within tumors. Tumor hypoxia is considered to be associated with radioresistance; by imaging hypoxic regions, clinicians can stratify patients by risk and...
2026-09-02
