Cell Therapeutics, Inc (CTI) announced today that it submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMEA) for Xyotax (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) who have ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2).
The application is based on a positive opinion CTI received from the EMEA’s Scientific Advice Working Party, which agreed to review the application based on the existing results of the phase III clinical trials of Xyotax, known as the STELLAR trials.
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 haematopoietic growth factor support.
In addition to improved tolerability, Xyotax offered more convenient administration compared to currently used treatments and a reduction in overall utilisation of medical resources compared to gemcitabine or vinorelbine.
The application will be formally reviewed for validation by the end of March. Upon validation, the marketing approval review process begins, which generally takes 15 to 18 months.
“This is an important milestone for CTI and demonstrates our commitment to bring Xyotax to this underserved group of patients. Currently there are no approved treatments for first-line use in PS2 patients with non-small cell lung cancer,” said James A Bianco, MD, President and CEO of CTI.
CTI also has an ongoing phase III clinical trial, in conjunction with the Gynecologic Oncology Group (GOG), studying Xyotax as monthly maintenance treatment in ovarian cancer.