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

Bridgewater, N.J. February 7, 2005 -- The U.S. Food and Drug Administration (FDA) has granted full approval to DOXIL (doxorubicin HCl liposome injection) for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. DOXIL, marketed in the United States by Tibotec Therapeutics, Division of Ortho Biotech Products, L.P., originally received accelerated approval for refractory ovarian cancer in June 1999. As a result of the full approval, the product label for DOXIL has been updated to include survival, time to disease progression and tumor response rate data from a randomized Phase III clinical study.

Under accelerated approval, DOXIL was indicated for the treatment of metastatic ovarian cancer in patients with disease that was refractory to both paclitaxel- and platinum-based chemotherapy regimens. This approval was based on tumor response rates from three Phase II studies. According to the terms of the accelerated approval, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) completed a randomized Phase III clinical study to formally demonstrate the drug's clinical benefit in patients with relapsed ovarian cancer. In March 2004, J&JPRD submitted a supplemental new drug application (sNDA) based on data from the Phase III study.

"The Phase III data provide evidence of the product's clinical benefit for patients with relapsed ovarian cancer," commented Alan N. Gordon, M.D., of the University of Arizona School of Medicine and Arizona Gynecologic Oncology, in Phoenix, Ariz., and lead author of the Phase III study, known as DOXIL Study 30-49.

In the randomized, multi-center, open-label, Phase III study, 474 patients with recurrent epithelial ovarian cancer were randomly assigned to receive either DOXIL 50 mg/m2 every 28 days or topotecan HCl 1.5 mg/m2/day for five consecutive days every 21 days. A total of 239 patients received DOXIL; 235 patients received


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