Drug For Chemotherapy-Related Hearing Loss Gets Fast-Tracked The U.S. Food and Drug Administration (FDA) is expediting development and approval of a drug that treats hearing loss in children receiving cisplatin, a platinum-based chemotherapy. The FDA designated Pedmark—the signature drug of Fennec Pharmaceuticals Inc., a small biotech in Durham, North Carolina—as a “breakthrough therapy,” indicating that preliminary clinical ... News in Brief
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News in Brief  |   July 01, 2018
Drug For Chemotherapy-Related Hearing Loss Gets Fast-Tracked
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Hearing Disorders / News in Brief
News in Brief   |   July 01, 2018
Drug For Chemotherapy-Related Hearing Loss Gets Fast-Tracked
The ASHA Leader, July 2018, Vol. 23, 11. doi:10.1044/leader.NIB6.23072018.11
The ASHA Leader, July 2018, Vol. 23, 11. doi:10.1044/leader.NIB6.23072018.11
The U.S. Food and Drug Administration (FDA) is expediting development and approval of a drug that treats hearing loss in children receiving cisplatin, a platinum-based chemotherapy.
The FDA designated Pedmark—the signature drug of Fennec Pharmaceuticals Inc., a small biotech in Durham, North Carolina—as a “breakthrough therapy,” indicating that preliminary clinical evidence shows the drug may demonstrate substantial improvement over available therapy for treatment of a serious condition.
According to Fennec’s website, more than 10,000 children in the U.S. and Europe may receive platinum-based chemotherapy. A recent NIH study found that cisplatin is eliminated from most areas of the body within days or weeks after treatment, but the drug remains much longer in the inner ear, and cells important for hearing die because of the extended exposure.
The incidence of hearing loss in children depends upon the dose and duration of cisplatin treatment, and there is no established preventive agent.
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July 2018
Volume 23, Issue 7