Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.
Centocor Ortho Biotech is evaluating the FDA's letter and will respond to the agency as quickly as possible.
The sNDA for DOXIL was submitted to the FDA in September 2008. DOXIL currently 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 bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib 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.