Centocor Ortho Biotech Statement on the FDA ODAC Opinion Regarding DOXIL(R) for Treatment of Advanced Bre...( ...),Health

HORSHAM, Pa., July 15 /PRNewswire/ -- Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of DOXIL(R) (doxorubicin HCI liposome injection) and docetaxel did not provide a sufficient benefit-risk profile for the treatment of women with locally advanced or metastatic breast cancer.

Women with locally advanced and metastatic breast cancer who have received prior anthracycline treatment have special treatment challenges, and Centocor Ortho Biotech Products, L.P. remains committed to bringing them new therapeutic options. The company believes the DOXIL-docetaxel combination has an important role in the treatment of advanced breast cancer and will work with the FDA to address the committee's concerns.

The committee provides non-binding recommendations based on its evaluation. The final decision regarding approval of the drug will be made by the FDA.

About DOXIL(R)( )

DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy. DOXIL in combination with VELCADE(R) (bortezomib) is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy. DOXIL is also indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

DOXIL is marketed in the United States by Centocor Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market the medication as CAELYX throughout the rest of the world, excluding Japan and Israel
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