US FDA grants full approval to DOXIL(R) following submission of phase III data

ancer, the most common side effects reported with DOXIL therapy included hand-foot syndrome, nausea, mouth sores (stomatitis), tiredness, abdominal pain, vomiting, constipation, rash, fever, reduced red blood cell count (anemia), reduced white blood cell count (neutropenia), weakness, hair loss, appetite loss and diarrhea. Some patients experienced infusion-related reactions and skin reactions. Hand-foot syndrome, also known as palmar-plantar erythrodysesthesia (PPE), is characterized by symptoms of swelling, pain, redness and, for some patients, peeling of the skin on the hands and feet; in 23 percent of patients, these symptoms were severe. In some patients enrolled in DOXIL clinical trials, heart-related side effects were reported, some of which were severe. Due to the serious, potentially permanent effects of some of these events, including the potential for bone marrow suppression, close monitoring is necessary.

About Ovarian Cancer

Ovarian cancer is the most deadly form of gynecologic cancer. According to the American Cancer Society, an estimated 22,220 American women are expected to be diagnosed with ovarian cancer in 2005 and more than 16,000 of these women are expected to die from the disease. The Ovarian Cancer National Alliance reports that approximately 50 percent of women diagnosed with ovarian cancer die from it within five years. However, nearly 75 percent of ovarian cancer cases are diagnosed in later stages when the disease is more difficult to treat and the chance of five-year survival is only about 25 percent.



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