September 10, 2009
FDA issues complete response letter to NDA for trabectedin combined with DoxilCentocor Ortho Biotech Products (a division of Johnson & Johnson) announced that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for trabectedin in combination with Doxil (doxorubicin HCI liposome injection) for the treatment of relapsed ovarian cancer. The FDA has requested additional information, including overall survival data from the company's ongoing trial and additional clinical pharmacology studies. The NDA for trabectedin was submitted to the FDA in November 2008.
Trabectedin is a novel cytotoxic antitumor agent that binds to the minor groove of DNA and bends it toward the major groove, causing DNA adducts that interfere with cell division and genetic transcription processes and DNA repair machinery. Doxil is an anthracycline approved for the treatment of AIDS-related Kaposi's sarcoma refractory to combination chemotherapy; ovarian cancer refractory to platinum-based chemotherapy; and multiple myeloma, in combination with bortezomib, in patients not previously treated with bortezomib and who have received at least one prior therapy.
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