Clinigen Group PLC - Staffordshire-based pharmaceuticals and services - Says the US Food & Drug Administration has granted approval to broaden the indication for Totect - or dexrazoxane - to now include reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer.
This affects women with metastatic breast cancer who have received a doxorubicin dose of 300 milligrams and who will continue to receive doxorubicin therapy to maintain tumor control.
"This exceptional accomplishment makes Totect the first and only FDA approved dexrazoxane product with a dual indication for the treatment of extravasation resulting from intravenous anthracycline chemotherapy as well as cardiomyopathy associated with doxorubicin in appropriately indicated women with metastatic breast cancer," said Clinigen Chief Executive Shaun Chilton
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By Ife Taiwo; ifetaiwo@alliancenews.com
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