Centocor Ortho Biotech has received a Complete Response Letter from the FDA regarding the New Drug Application (NDA) for trabectedin, when administered in combination with DOXIL (doxorubicin HCI liposome injection). It is intended for the treatment of women with relapsed ovarian cancer.
Reportedly, the agency has requested additional information, including overall survival data from the company’s ongoing pivotal trial and additional clinical pharmacology studies.
Centocor Ortho believe that trabectedin has an important role in the treatment of patients with ovarian cancer. However, the company is also reviewing the FDA’s letter and will respond to the agency’s questions as quickly as possible.
Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata.