The validation of the marketing authorization application (MAA) for Xyotax initiates the marketing approval review process, which generally takes 15 to 18 months. 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.
James Bianco, president and CEO of Cell Therapeutics (CTI), said: “CTI looks forward to working with the European Medicines Agency (EMEA) as it begins the review process for Xyotax. This is an important step toward making Xyotax available for lung cancer patients in Europe.”