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Fennec Pharmaceuticals Inc (FENC) delivers innovative therapies targeting cisplatin-induced hearing loss in pediatric cancer patients. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic partnerships.
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Fennec Pharmaceuticals announced a significant milestone with the positive opinion from the CHMP for Pedmarqsi™ (sodium thiosulfate), aimed at reducing the risk of cisplatin-induced hearing loss in pediatric patients diagnosed with localized, non-metastatic solid tumors. This potential approval marks Pedmarqsi as the first therapy in the EU targeting this critical unmet need, following its FDA approval in the U.S. in September 2022. Clinical trials demonstrated a significant reduction in hearing loss incidences with Pedmarqsi alongside cisplatin. The European Commission's ratification is anticipated by early June 2023, which could benefit approximately 5,000 eligible children annually.