Schering-Plough Corporation announced that the European Commission of the European Union (EU) has granted centralized marketing authorization to Caelyx (pegylated liposomal doxorubicin hydrochloride) as monotherapy for metastatic breast cancer in patients who are at increased cardiac risk.
Commission approval results in marketing authorization with unified labeling that is immediately valid in all 15 EU-Member States as well as in Iceland and Norway. The Commission's decision follows its recommendation for approval in October 2002 by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA).
Caelyx is currently marketed in the EU for the treatment of advanced ovarian cancer in women who have failed first-line, platinum-based therapy, and for the treatment of AIDS-related Kaposi's sarcoma in patients with low CD4 counts (<200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.
In the breast cancer clinical registration program, Caelyx was found to have similar efficacy to conventional doxorubicin, which is among the most active agents used to treat metastatic breast cancer. Additionally, Caelyx was found to have a significantly lower incidence of cardiotoxicity and alopecia (hair loss) than doxorubicin. Cardiotoxicity has been the limiting toxicity of doxorubicin treatment.
Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride, a widely used cytotoxic agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors. Schering-Plough has exclusive international marketing rights to Caelyx, except in Japan and Israel, through a distribution agreement with Alza, a wholly owned subsidiary of Johnson & Johnson of New Brunswick, N.J. The product is marketed in the United States under the trade name Doxil by Ortho Biotech Products, L.P., a biotechnology subsidiary of Johnson & Johnson.