European Union/United States of America - The Committee for Proprietary Medicinal Products (CPMP) has recommended approval of pegylated liposomal doxorubicin hydrochloride (Caelyx®) for the treatment of advanced ovarian cancer in women who have failed first-line platinum-based therapy (1). The application proposes that Caelyx® be administered intravenously once every four weeks for as long as the disease does not progress and the patient continues to tolerate treatment. The product has previously received centralized marketing authorization in the European Union for the treatment of AIDS-related Kaposi sarcoma and extensive mucocutaneous or visceral disease (2).
In the USA, doxorubicin (Doxil®) was approved in 1999 (under an accelerated review process designed to address urgent unmet needs) to treat metastatic ovarian cancer in women whose disease is refractory to paclitaxel and platinum-based chemotherapy. The product is a liposomal formulation of doxorubicin, using a novel targeted delivery system to help evade recognition and uptake by the immune system. This allows liposomes and their pharmaceutical content to circulate in the body longer (3).
Ovarian cancer is the second most common gynaecological cancer in the USA; an estimated 25 200 cases were diagnosed in 1999 and approximately 35 000 new cases are diagnosed in the European Union every year. Between 55 to 75% of women relapse within two years.
1. Publication of CPMP opinions at http://www.eudra.org/humandocs/humans/opinion.htm June 2000.
2. Schering Plough, company news on line. http://www.schering-plough.com (3 July 2000).
3. Alza corporation, http://www.alza.com (3 July 2000).