Fennec Reports Growing PEDMARK Demand as New Data Support Hearing Protection During Cisplatin Treatment

fennec pharmaceuticals hearing loss cisplatin
HHTM
August 13, 2026

Fennec Pharmaceuticals reported continued growth in demand for PEDMARK® (sodium thiosulfate), its treatment designed to reduce the risk of hearing loss associated with cisplatin chemotherapy, as new clinical evidence adds support for protecting hearing without compromising cisplatin’s antitumor activity.

PEDMARK net product sales reached $17.1 million during the second quarter of 2026, up 78% from $9.7 million during the same period last year. Fennec said demand increased across both new and existing accounts following an expansion of its commercial organization, with record demand continuing into the third quarter.

The growth comes as researchers continue to examine the role of sodium thiosulfate in preventing cisplatin-induced ototoxicity, including its potential use across a broader range of ages and cancer types.

“Our second quarter reflects another period of strong execution across the business, highlighted by our seventh consecutive quarter of growth. We continue to build momentum by investing in the evidence that will shape the future of PEDMARK® (sodium thiosulfate), with important data presented at ASCO and a growing pipeline of investigator-sponsored studies that we believe will further expand our understanding of its potential”

–Jeff Hackman, CEO of Fennec Pharmaceuticals

Protecting Hearing While Preserving Cancer Treatment

Cisplatin is a widely used and effective chemotherapy for numerous cancers, but it can damage the inner ear and cause permanent hearing loss. An important consideration surrounding otoprotective treatments is whether protecting the ear could interfere with cisplatin’s ability to fight cancer.

Fennec highlighted research presented during the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting that provided additional evidence addressing that concern.

According to the company, real-world evidence presented at ASCO reinforced that PEDMARK can be integrated into patient care when administered approximately six hours after cisplatin without compromising cisplatin’s established antitumor activity.

The findings add to previous clinical evidence supporting delayed administration of sodium thiosulfate. A pooled analysis of clinical trial data found no statistically significant differences in overall survival, event-free survival, or objective chemotherapy response between patients receiving sodium thiosulfate and control groups.

The timing of treatment is an important part of the approach. PEDMARK is administered after cisplatin rather than simultaneously, with the goal of allowing cisplatin to exert its antitumor effects before sodium thiosulfate is given to help reduce its toxic effects on the inner ear.

Research Expands to Additional Patients

PEDMARK is currently FDA approved to reduce the risk of cisplatin-associated ototoxicity in pediatric patients one month of age and older with localized, non-metastatic solid tumors. The National Comprehensive Cancer Network also gives sodium thiosulfate a Category 2A recommendation for adolescent and young adult patients.

Four independently led studies included in the 2026 ASCO program examined PEDMARK across multiple patient populations and tumor types. Fennec said the research is expanding understanding of its potential use among adolescent and young adult (AYA) and adult patients.

Additional investigator-sponsored studies are examining sodium thiosulfate in patients with several cancers where cisplatin remains an important part of treatment and treatment-related hearing loss is a concern.

Growing Adoption

Fennec said demand for PEDMARK continued to increase during the second quarter, with growth across both established and new accounts. The company also reported substantial year-over-year growth during the first half of 2026, reflecting broader adoption of the treatment.

The combination of growing clinical use and continued research reflects increasing attention to a longstanding challenge in cancer care: reducing the risk of permanent treatment-related hearing loss while preserving the effectiveness of cisplatin chemotherapy.

About PEDMARK

PEDMARK® (sodium thiosulfate injection) is FDA approved to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients one month of age and older with localized, non-metastatic solid tumors.

The therapy is administered intravenously following cisplatin treatment and was evaluated in two randomized Phase 3 clinical studies, COG ACCL0431 and SIOPEL 6. PEDMARK became the first FDA-approved therapy specifically indicated to reduce the risk of cisplatin-induced ototoxicity when it received approval in September 2022.

Outside the United States, the therapy is marketed as PEDMARQSI®.

 

Source: Fennec Pharmaceuticals

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