Schering-Plough Corporation reported that the European Union's (EU) Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of Caelyx (pegylated liposomal doxorubicin hydrochloride) as monotherapy for metastatic breast cancer in patients who are at increased cardiac risk.

The CPMP recommendation serves as the basis for a European Commission approval, which typically follows in approximately three to four months. Commission approval will result in a Marketing Authorization with unified labeling that will be valid in all 15 EU-Member States as well as in Iceland and Norway.

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 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 than doxorubicin. Cardiotoxicity has been the limiting toxicity of doxorubicin treatment.

Breast cancer is the most common cancer occurring in women, with an estimated 12 percent of women worldwide being at risk of developing the disease at some time in their lives. For patients with end-stage, or metastatic breast cancer, five-year survival is only about 20 percent, and average survival is two years after documentation of metastasis and beginning chemotherapy. Breast cancer for that reason is the second-leading cause of cancer deaths in women overall, behind lung cancer, and is the leading cause of death in women 40 to 55 years old. While mortality rates from breast cancer have declined slightly in the past decade due to advances in early detection and disease management, they remain high. Currently, nearly 67,000 women in the major European countries die from breast cancer each year. About 10 percent to 15 percent of all breast cancer diagnoses are metastatic breast cancer and another 40 percent of cases have involved axillary lymph nodes (LNs). In about 70 percent of these latter patients, the disease eventually relapses, with metastatic breast cancer occurring in about two-thirds of these cases.

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.