CTI further refines Xyotax population in new Phase III
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A confirmatory Phase III trial of Cell Therapeutics' polymer-linked paclitaxel Xyotax is recruiting women with advanced non-small cell lung cancer who have premenopausal estrogen levels (>30 pg/mL). The PGT307 trial, designed under a special protocol assessment with FDA, will enroll 450 women with NSCLC performance status 0, 1, or 2, who will be randomized to Xyotax (paclitaxel poliglumex) plus carboplatin or paclitaxel/carboplatin. CTI has been highlighting its plans for a normal estrogen level protocol to support a "gender medicine" NDA (1Pharmaceutical Approvals Monthly, December 2006, p. 11). An earlier gender-specific trial, the PIONEER study, enrolled women with both normal and abnormal estrogen levels, but was terminated late last year due to early cycle deaths in both arms. CTI has been trying to isolate the effect observed in women in its STELLAR pivotal program. The traditional gender-neutral program failed to meet endpoints in the total NSCLC population, but showed a benefit in women...
You may also be interested in...
CTI Xyotax PIONEER Study Closes In Favor Of Normal Estrogen Level Protocol
Cell Therapeutics will submit a new Xyotax (paclitaxel poliglumex) trial protocol to FDA by the end of the month after closing its Phase III PIONEER gender-specific lung cancer trial
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says
The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.