Dexrazoxane Nearer US Approval

The US Food and Drug Administration's Oncologic Drugs Advisory Committee has recommended approval for Pharmacia's injectable agent Zinecard (dexrazoxane) for preventing/ reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in patients who have received potentially cardiotoxic doses of doxorubicin.

Based on the data which was presented at the advisory committee meeting, the panel voted eight to one in favor of recommending that Zinecard should be approved under the FDA's accelerated approval mechanism.

Dexrazoxane was first approved in Italy in 1992 by its originator, EuroCetus, and is now marketed in several European countries under the trade name Cardioxane.