Two CRLs later, FDA endorses drug to prevent hearing loss associated with chemo

After rejecting it twice, the FDA has finally approved a new drug for lowering the risk of hearing loss among children being treated for cancer with chemotherapy.

Pedmark, as Fennec Pharma calls its drug, is a formulation of sodium thiosulfate. Given that ototoxicity is a major dose-limiting side effect of cisplatin chemotherapy and there were no available treatments for it, the FDA granted North Carolina-based Fennec both fast track and breakthrough therapy designations back in 2018, and put the drug on priority review two years later.