The Food and Drug Administration (FDA) has granted fast track designation to Pedmark (sodium thiosulfate; Fennec Pharmaceuticals), for the prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).
Two Phase 3 clinical trials evaluating sodium thiosulfate, an antioxidant, for reduction of ototoxicity and hearing loss in children (ages 1–18) have been completed.
The Clinical Oncology Group Protocol ACCL0431 trial enrolled 125 pediatric patients newly diagnosed with a germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy. While the SIOPEL 6 trial enrolled 109 patients with hepatoblastoma. Results from both trials showed that sodium thiosulfate protected against hearing loss (the primary endpoint).
“We look forward to the more frequent interactions with the Agency that the Fast Track designation provides, as we prepare for the NDA filing,” said Rosty Raykov, CEO of Fennec. The Fast Track designation means that Pedmark may be eligible for Priority Review once the Company submits a New Drug Application.
There are currently no drugs approved for the prevention of platinum-induced ototoxicity.
For more information visit Fennecpharma.com.