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Doxil Approved For Refractory Ovarian Cancer PALO ALTO, CA -- June 29, 1999 -- The United States Food and Drug Administration has approved Alza Corp.’s Doxil(R) (doxorubicin HCl liposome injection) for the treatment of refractory ovarian cancer. Doxil is indicated for women with ovarian cancer who have disease that is refractory to paclitaxel- and platinum-based chemotherapy regimens, which are current first-line therapies. Refractory ovarian cancer is defined as disease that progresses during treatment or within six months after completing treatment. This indication is based on objective tumour response rates. No results are available from controlled trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in disease-related symptoms or increased survival. "In an area that lacks effective and tolerable alternatives, Doxil represents a major advance for patients who are unresponsive to currently available regimens," said Maurie Markman, M.D., chairman of the department of hematology and medical oncology at the Cleveland Clinic Taussig Cancer Center. "There is a great need for more options to offer these patients because so many women experience disease progression while receiving paclitaxel- and platinum-based chemotherapy. “The approval of Doxil is truly encouraging news for women with ovarian cancer and physicians alike." With the new indication, Doxil is the first and only liposomal cytotoxic agent approved to treat a solid tumour. Doxil was originally approved in 1995 for the treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination therapy or in patients who are intolerant to such therapy. The FDA has agreed that there is an unmet medical need for advanced ovarian cancer patients and evaluated Doxil's supplemental new drug application under accelerated approval regulations. Doxil also was granted orphan drug status for ovarian cancer, which provides for seven years of market exclusivity upon approval. Ovarian cancer is the second most common gynaecologic cancer; it causes more deaths than any other cancer of the female reproductive system. An estimated 25,200 new cases of ovarian cancer will be diagnosed in the U.S. in 1999, and approximately 14,500 women are expected to die from the disease this year alone. Despite improvements in therapy, first-line chemotherapy fails to provide response rates in more than 20 percent of patients and approximately 40 percent to 50 percent of women who do experience a response to initial treatment relapse within two years. Because ovarian cancer has few early symptoms, most patients are not diagnosed until their disease has progressed to an advanced stage, which contributes to the high mortality rate. Current treatment for late-stage ovarian cancer has a very poor response rate and the toxic side effect profiles of cytotoxic agents limit their usage. Doxil is a liposomal formulation of doxorubicin, an intravenous chemotherapy agent. Doxil uses a novel, targeted delivery system called STEALTH(R) technology to help evade recognition and uptake by the immune system. Unlike conventional liposomes, STEALTH liposomes evade detection and destruction by the immune system so they can circulate in the body longer. A long circulation time increases the likelihood that the liposomes and their pharmaceutical contents will reach their targeted tumour site. Studies evaluating Doxil included three phase II trials conducted among women with relapsed or refractory ovarian cancer, as well as preliminary results of a phase III randomised trial. Patients in the phase II studies with refractory ovarian cancer demonstrated a 13.8 percent response rate, defined as a reduction in tumour size of at least 50 percent. This response rate was supported by an interim analysis of phase III data. Alza is continuing to evaluate the efficacy and safety of Doxil in refractory ovarian cancer in randomised phase III clinical studies. In clinical trials, the most common side effects reported with Doxil therapy included reduced white blood cell count (neutropenia), reduced red blood cell count (anemia), nausea, hand-foot syndrome, soreness of the mouth (stomatitis), vomiting, diarrhea, constipation, appetite loss, tiredness, weakness, rash and mild hair loss. Some patients experienced infusion-related reactions and skin reactions. Hand-foot syndrome, also known as Palmar-plantar erythrodysesthesia (PPE), is characterised by symptoms of swelling, pain, redness and, for some patients, peeling of the skin on the hands and feet. In 17 percent of patients, these symptoms were moderate to severe. In some patients, 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. Related Links: Doxil, Alza Corp. E-mail this page to a friend or colleague! To print, use this version