ARTICLE | Clinical News

Totect dexrazoxane regulatory update

July 4, 2011 7:00 AM UTC

EMA's CHMP recommended that dexrazoxane-containing medicines should be restricted to adult patients with advanced or metastatic breast cancer who have already received treatment with anthracyclines doxorubicin and epirubicin and contraindicated in children and adolescents. Last year, CHMP began the review due to concerns that the medicines could be linked to an increased risk of acute myelogenous leukemia (AML), myelodyspastic syndrome (MDS) and solid tumors in pediatric patients receiving the drugs to prevent anthracycline-induced cardiotoxicity (see BioCentury, Aug. 2, 2010). The agency concluded the benefits of dexrazoxane only outweigh the risks in adults who have already received a minimum cumulative dose of 300 mg/m 2 of doxorubicin or 540 mg/m 2 of epirubicin, and also to reduce the dose ratio of dexrazoxane to doxorubicin to 10:1 from 20:1. ...