FDA deals new blow to Fennec’s hearing loss treatment for pediatric cancer patients


The FDA has dealt another blow to Fennec Pharmaceutical’s attempt to market a drug to treat hearing loss in pediatric cancer patients. The agency issued a second comprehensive response letter targeting manufacturing issues.

Following a recent pre-approval inspection of its manufacturing plant, the regulatory agency noted that “deficiencies have been identified” at the site, the company said. Details of the manufacturing issues were not disclosed and Fennec said he would request a meeting with the agency once the official CRL is received.

In August 2020, the FDA refused to approve Pedmark for similar reasons. At the time, Fennec resubmitted its request and the agency set a target action date of November 27 to make a decision. Pedmark is Fennec’s only clinical drug candidate in its pipeline.

Pedmark, which is administered intravenously, targets children aged 1 month to 18 years who have undergone platinum-based chemotherapy using cisplatin. Although commonly used in the treatment of a range of cancers in children, the therapies can cause permanent hearing loss. Fennec said that two late stage studies of Pedmark, which are also under review by the European Medicines Agency, indicated a reduction in cisplatin-induced hearing loss in children with various cancers such as cancer of the liver, bones and brain.

More than 10,000 children in the United States and Europe could be treated with platinum-based chemotherapy, the company said. There are no approved therapies to prevent cisplatin-induced hearing loss in the United States


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