CT submits Xyotax MAA to EMEA

USA-based Cell Therapeutics has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for Xyotax (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer who have Eastern Cooperative Oncology Group performance status 2. The application is based on a positive opinion that CT received from the EMEA's Scientific Advice Working Party, which agreed to review the application based on the existing results of the Phase III STELLAR trials.

According to CT, in the STELLAR 4 study, use of the drug as monotherapy 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. These included 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. The application will be formally assessed for validation by the end of March. After this, the marketing approval review process begins, which generally takes between 15 to 18 months.