Fennec Pharmaceuticals Inc. announced that the National Comprehensive Cancer Network® (NCCN) has updated its clinical practice guidelines for Adolescent and Young Adult (AYA) Oncology to include PEDMARK® (sodium thiosulfate injection) to help reduce the risk of ototoxicity (hearing loss) associated with cisplatin use in pediatric patients with localized, non-metastatic solid tumors. The update to the Clinical Guidelines for AYA Oncology follows the U.S. Food and Drug Administration (FDA) approval of PEDMARK in September 2022, which was based upon safety and efficacy data from two pivotal open-label, randomized Phase 3 trials (Clinical Oncology Group [COG] Protocol ACCL0431 and SIOPEL 6), which compared PEDMARK plus a cisplatin-based regimen to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients. Fennec Pharmaceuticals commercially launched PEDMARK in the U.S. in October 2022.

The goal of the NCCN Guidelines for AYA Oncology is to identify issues specific to the AYA population; recommend interventions unique to the AYA population; educate physicians regarding the prevalence of cancer in AYAs; discuss long-term consequences; explain considerations related to the management in AYA patients that aims to improve treatment tolerance, compliance and clinical outcome; and promote participation in clinical trials.