CTI files Xyotax SPA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cell Therapeutics is requesting a special protocol assessment for its revised Phase III Xyotax (paclitaxel poliglumex) trial for women with advanced lung cancer, the firm says March 20. The company closed its Xyotax PIONEER trial in December 2006 after the drug missed its primary endpoint in the overall population (1Pharmaceutical Approvals Monthly January 2007, In Brief). The new trial (PGT307) will focus on women with normal estrogen levels and will study Xyotax in combination with carboplatin versus paclitaxel/carboplatin. The company plans on enrolling 450 patients and will conduct an interim analysis in the first half of 2008. CTI also announced plans on filing its NDA for pixantrone as a salvage therapy for patients with aggressive non-Hodgkins lymphoma in early 2008. Data from two studies of pixantrone in aggressive NHL are expected in 2007. The company had hoped its adaptive design would enable it to file in 07 (2Pharmaceutical Approvals Monthly August 2006, p. 3); the oncologic has been granted fast-track status...