Fennec Pharma Receives FDA Approval of Pedmark

The FDA approved Fennec Pharma’s Pedmark (sodium thiosulfate injection) for reducing the risk of hearing loss associated with cisplatin in pediatric patients aged one month and older with localized, non-metastatic solid tumors.

The agency had previously declined to grant approval in August 2020 and again in November 2021 because of unresolved manufacturing issues.

The approval was supported by positive results from two clinical trials. In one study, the incidence of hearing loss was 39 percent in patients who received cisplatin-based chemotherapy with sodium thiosulfate, compared with 68 percent in the treatment arm that received cisplatin alone.

The FDA approval makes Pedmark the first approved treatment for preventing cisplatin-induced hearing loss. The European Medicines Agency is currently reviewing a marketing authorization application for sodium thiosulfate under the tradename Pedmarqsi.