Fennec Launches PEDMARK® Real-World Study at Tampa General to Reduce Cisplatin Ototoxicity
Fennec Pharmaceuticals partnered with Tampa General Hospital Cancer Institute and USF Health Morsani College to launch a real-world evaluation of PEDMARK® (sodium thiosulfate) for reducing cisplatin-induced ototoxicity in adolescent, young adult and adult patients with non-metastatic solid tumors. PEDMARK holds FDA approval for pediatric use and a NCCN 2A recommendation for AYA patients.
1. Collaboration with Tampa General Hospital Cancer Institute
Fennec Pharmaceuticals has partnered with Tampa General Hospital Cancer Institute and USF Health Morsani College of Medicine to initiate a real-world evaluation of sodium thiosulfate injection (PEDMARK®) in adolescent, young adult and adult patients with non-metastatic solid tumors receiving cisplatin chemotherapy.
2. Study Objectives and Design
The study will analyze clinical utility through real-world data and audiology monitoring to assess PEDMARK’s ability to reduce the incidence of cisplatin-induced ototoxicity, aiming to inform future research and clinical practice on hearing preservation strategies.
3. Regulatory Status and Clinical Implications
PEDMARK is FDA-approved for pediatric patients with localized non-metastatic solid tumors and carries a NCCN 2A recommendation for adolescent and young adult populations; positive real-world outcomes could support broader adoption and potential label updates.