Cell Therapeutics, Inc. (CTI) today announced that the European Medicines Agency (EMEA) has accepted for review CTI's Marketing Authorization Application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). CTI submitted the MAA at the beginning of March. The validation of the MAA for XYOTAX initiates the marketing approval review process, which generally takes 15 to 18 months. The application is based on advice from the Scientific Advice Working Party, or SAWP, at the EMEA. The EMEA agreed that switching the primary endpoint from superiority to non-inferiority is feasible if the retrospective justification provided in the marketing application is adequate. The discussions with the SAWP focused on using the STELLAR 4 study as primary evidence of non-inferiority and the STELLAR 3 study as supportive of the MAA.
In the STELLAR 4 trial, single-agent XYOTAX resulted in comparable survival to gemcitabine or vinorelbine in first-line patients and, with the exception of neuropathy known to be associated with taxane therapy, demonstrated significant reduction in several clinically meaningful toxicities, such as severe neutropenia and infection, and in the requirement for transfusions and use of hematopoietic growth factor support. In addition to improved tolerability, XYOTAX offered more convenient administration compared to currently used treatments and a reduction in overall utilization of medical resources compared to gemcitabine or vinorelbine.
"CTI looks forward to working with the EMEA as it begins the review process for XYOTAX," said James A. Bianco, M.D., President and CEO of CTI. "This is an important step toward making XYOTAX available for lung cancer patients in Europe."
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