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.

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