Posted by Michael Wonder on 11 Nov 2020
Clinigen's Totect (dexrazoxane) receives FDA approval for new indication to treat incidence and severity of cardiomyopathy associated with doxorubicin in women with metastatic breast cancer
10 November 2020 - Clinigen announced today that the FDA has granted approval to broaden the indication for Totect to now include reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m² and who will continue to receive doxorubicin therapy to maintain tumour control.
Totect was first approved in September 2007 for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
