Posted by Michael Wonder on 21 Mar 2018
Fennec Pharmaceuticals receives fast track designation by FDA for Pedmark
21 March 2018 - Fennec Pharmaceuticals today announced that the U.S. FDA has granted Pedmark (a unique formulation of sodium thiosulfate) fast track designation for prevention of cisplatin-related ototoxicity in paediatric patients with standard risk hepatoblastoma (SR-HB).
There are currently no drugs approved in the US for this condition. Fast track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.
STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumour, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localised tumours.
