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Complete Response Letter for Centocor’s Doxil

J&J unit Centocor Ortho Biotech Products received a Complete Response letter from the FDA regarding its sNDA for Doxil (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of metastatic breast cancer.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

J&J unit Centocor Ortho Biotech Products received a Complete Response letter from the FDA regarding its sNDA for Doxil (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of metastatic breast cancer. Centocor is evaluating the letter and plans to respond to the agency as quickly as possible. The sNDA for Doxil was submitted in September 2008.

Doxil is currently indicated for the treatment of ovarian cancer that 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 taken 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 U.S. by Centocor Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough has exclusive rights under a licensing agreement to market the drug as Caelyx throughout the rest of the world, excluding Japan and Israel.

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