Doxil® Receives Full Approval for Recurrent Ovarian Cancer

Doxil® Receives Full Approval for Recurrent Ovarian Cancer

Recently the Food and Drug Administration (FDA) granted full approval for the drug Doxil® to be used for patients who have ovarian cancer and have experienced disease progression or stopped responding while on a platinum-based chemotherapy. Previously, Doxil® had only been indicated for patients with metastatic disease who had not responded to either platinum or taxane-based chemotherapies.

Ovarian cancer is a malignancy that arises from various different cells within the ovaries. Approximately 25,000 new cases of ovarian cancer are diagnosed in the United States each year. Unfortunately, ovarian cancer often goes undetected until the disease has progressed into the abdomen or spread to other organs. The best treatment strategy for cancer is to prevent its occurrence or to detect it early when it is most treatable. Current treatment includes surgery, chemotherapy and possibly radiation. Unfortunately, ovarian cancer is often difficult to treat and the cancer often recurs, requiring multiple chemotherapy treatment regimens.

The initial approval for Doxil® had been based on tumor response rates; however, new studies, which have been reviewed by the FDA, include improvements in overall survival time and overall response rates. One trial in particular included 474 women with epithelial ovarian cancer. Patients were randomized to receive either Doxil® (50mg/m2) every 4 weeks or Hycamtin® (topotecan) (1.5mg/m2/day) for 5 consecutive days, every 3weeks.

Results of the study indicated that although the time to disease progression was not significantly different between the two groups, overall survival was improved with Doxil® when compared to Hycamtin® (14.4 months vs. 13.7months). Overall response rates were 19.7% in the Doxil® group, compared to 17% among the Hycamtin® group.

Researchers concluded that Doxil® appears to be a reasonable treatment alternative to Hycamtin® as a second-line therapy in ovarian cancer patients.

References:

Doxil® prescribing information. Available at: http://www.doxil.com/common/prescribing_information/DOXIL/PDF/DOXIL_PI_Booklet.pdf. Accessed February 2005.

Food and Drug Administration. Available at: . Accessed February 2005.

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