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# Fennec Pharma NDA Priority Review for Pedmark
- URL: https://www.fdaweb.com/fennec-pharma-nda-priority-review-for-pedmark/
- Published: 2020-04-14T12:00:00.000Z
- Updated: 2026-09-14T16:11:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146565

FDA has accepted for priority review a Fennec Pharmaceuticals NDA for Pedmark (sodium thiosulfate), indicated for preventing ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients one month to 18 years of age with localized, non-metastatic, solid tumors. The agency set a user fee review action target date of 8/10.

The company says it is common for platinum-based therapies to cause ototoxicity in pediatric patients. The submission is based on data from two Phase 3 clinical studies of survival and reduction of ototoxicity — The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6\. Both studies have been completed, according to the company. Data showed that sodium thiosulfate protects against cisplatin-induced hearing loss in children and is not associated with serious adverse events, it says.

A submission for the same indication is also under evaluation by the European Medicines Agency. Pedmark has received a Breakthrough Therapy and Fast Track Designation by FDA 3/2018.