DUBLIN, Ohio--Pharmacia Inc. has received FDA approval to market Zinecard (dexrazoxane for injection), a new agent for reducing the incidence and severity of cardiomyopathy associated with doxorubicin(Drug information on doxorubicin) (Adriamycin) administration in women with metastatic breast cancer. The indication is for patients who have received a cumulative doxorubicin dose of 300 mg/m² and, in their physician's opinion, would benefit from continuing doxorubicin therapy.
Data from three prospective randomized controlled studies demonstrated that patients with advanced breast cancer treated with fluorouracil(Drug information on fluorouracil), Adriamycin, and cyclophosphamide(Drug information on cyclophosphamide) (FAC) plus Zinecard had a much lower incidence and risk of cardiotoxicity than patients treated with FAC without Zinecard, the company said. In addition, patients treated with Zinecard were able to receive much higher cumulative doses of doxorubicin than those who did not get the cardioprotective agent.
There is some evidence that the use of Zinecard concurrently with the initiation of FAC interferes with the antitumor effects of the regimen, and this use is not recommended, the company said.
Pharmacia will conduct an additional prospectively randomized study to establish whether the effect of Zinecard after a cumulative 300 mg/m² doxorubicin dose influences time to progression.