Zinecard Approved For Marketing

September 1, 1995

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 (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.

DUBLIN, Ohio--Pharmacia Inc. has received FDA approval to marketZinecard (dexrazoxane for injection), a new agent for reducingthe incidence and severity of cardiomyopathy associated with doxorubicin(Adriamycin) administration in women with metastatic breast cancer.The indication is for patients who have received a cumulativedoxorubicin dose of 300 mg/m² and, in their physician's opinion,would benefit from continuing doxorubicin therapy.

Data from three prospective randomized controlled studies demonstratedthat patients with advanced breast cancer treated with fluorouracil,Adriamycin, and cyclophosphamide (FAC) plus Zinecard had a muchlower incidence and risk of cardiotoxicity than patients treatedwith FAC without Zinecard, the company said. In addition, patientstreated with Zinecard were able to receive much higher cumulativedoses of doxorubicin than those who did not get the cardioprotectiveagent.

There is some evidence that the use of Zinecard concurrently withthe initiation of FAC interferes with the antitumor effects ofthe regimen, and this use is not recommended, the company said.

Pharmacia will conduct an additional prospectively randomizedstudy to establish whether the effect of Zinecard after a cumulative300 mg/m² doxorubicin dose influences time to progression.