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.
Data from three prospective randomized controlled studies demonstrated
that patients with advanced breast cancer treated with fluorouracil,
Adriamycin, and 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
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.