In addition, a shift in the non-inferiority margin may also be justified if the safety profile of Xyotax (paclitaxel poliglumex) is superior to comparators in terms of serious side effects and/or quality of life or use of rescue medications.
Cell Therapeutics (CTI) plans to file a marketing authorization application (MAA) in Europe in the first half of 2007 for Xyotax as a single agent for first-line treatment of non-small cell lung cancer (NSCLC) in ECOG performance status 2 patients.
“This is a very exciting outcome for CTI and more importantly for patients with lung cancer. We now have a clear route for potential approval in both the US and Europe with both regulatory agencies willing to accept the STELLAR trial results as supportive or, in the case of the EMEA, as pivotal,” commented Dr James Bianco, president and CEO of CTI. “This could have a significant positive impact on both the time and cost for bringing this drug to market.”