Rolling submission underway to FDA for Pedmark in ototoxicity.- Fennec Pharma.

Fennec Pharmaceuticals has initiated a rolling New Drug Application (NDA) for Pedmark (sodium thiosulfate infusion) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic, solid tumors. The Company is targeting U.S. approval of Pedmark in the second half of 2019. Pedmark has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations from the FDA.

Pedmark has been studied by cooperative groups in two Phase III clinical studies of survival and reduction of ototoxicity: COG ACCL0431 and SIOPEL 6. Both studies are complete. COG ACCL0431 enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors. COG ACCL0431 final results were published in the Lancet Oncology. SIOPEL 6 final results were published in the New England Journal of Medicine.

Comment: In Europe, Fennec intends to submit its Marketing Authorisation Application (MAA) via the European Medicines Agency�s Paediatric-use marketing authorisation (PUMA) pathway next year. This is supported by the Paediatric Committee (PDCO) recently approved Paediatric Investigation Plan (PIP).