The Food and Drug Administration approved Pedmark for the prevention of chemotherapy-induced hearing loss in pediatric patients with localized, nonmetastatic solid cancers.
The Food and Drug Administration (FDA) approved Pedmark (sodium thiosulfate) to prevent ototoxicity (hearing and/or balance issues) associated with cisplatin treatment for children aged one month or older who have localized, nonmetastatic solid cancers.
The approval is based off findings from two clinical trials — SIOPEL 6 and COG ACCLO431 — involving pediatric patients who were undergoing cisplatin-based chemotherapy for their cancer.
SIOPEL 6 included 114 patients with standard-risk hepatoblastoma (a rare type of cancer that originates in the liver) who were undergoing pre-surgical chemotherapy with a cisplatin-based regimen. Half the patients were randomly assigned to receive Pedmark alongside cisplatin, while the other half did not.
Findings showed that the incidence of hearing loss was lower in the group of patients who received Pedmark (39%) compared with the group that did not (68%).
The COG ACCL0431 clinical trial involved 125 children who had solid tumors and were undergoing treatment with a cisplatin-based regimen. Similar to SIOPEL 6, half the patients received Pedmark with cisplatin and the other half did not.
The researchers assessed hearing loss at the start of treatment, as well as four weeks after the final cisplatin treatment. Incidence of hearing loss was lower in patients who received Pedmark (44%) compared with those who received cisplatin alone (58%).
The most common side effects that were seen more frequently in patients who received Pedmark compared to those who did not were vomiting, nausea, decreased hemoglobin (a protein in the blood that carries oxygen), increased sodium in the blood and low potassium levels in the blood.
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