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Fennec Pharmaceuticals Announces Updated NCCN Clinical Practice Guidelines Recommend PEDMARK® (sodium thiosulfate injection) to Reduce the Risk of Cisplatin-Induced Hearing Loss in Pediatric Patients
~ PEDMARK is the First and Only FDA-Approved Therapy Indicated to Reduce the Risk of Ototoxicity Associated with Cisplatin in Pediatric Patients with
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ PEDMARK is the First and Only FDA-Approved Therapy Indicated to Reduce the Risk of Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-metastatic Solid Tumors ~ ~ The 5-year Survival Rate for Childhood Cancers Due to Major Treatment Advances is Now 85 Percent or Higher,1 Underscoring Need to Mitigate the Profound Impact Hearing Loss Can Have on a Child’s Learning and Development ~ RESEARCH TRIANGLE PARK, N.C., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today 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 use of cisplatin chemotherapy, an indispensable treatment of choice in many pediatric cancer cases, can be toxic to the ears and frequently causes permanent and irreversible bilateral hearing loss. In fact, permanent hearing loss occurs in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent2,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “We applaud NCCN for not only recognizing the importance of routine monitoring for hearing loss – which can have a profound impact on children’s learning and development at all ages – and also for providing a clear recommendation for the routine use of PEDMARK, a recently approved FDA therapeutic that may help reduce this unfortunate treatment-related side effect. Moreover, the FDA has directed that PEDMARK is not substitutable with other sodium thiosulfate products as part of the approved prescribing label.3” 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 Pharmaceutica...