Pharmacyclics Xcytrin misses endpoint
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pharmacyclics' Xcytrin (motexafin gadolinium) fails to show statistical significance for lung cancer patients with brain metastases in the 554-patient Phase III SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial, the firm reports Dec. 19. For the primary endpoint of time to neurologic progression (TNP), patients receiving whole brain radiation therapy plus Xcytrin had a median TNP of 15.4 months compared to 10 months for patients receiving radiation alone (p=0.122, hazard ratio=0.78). Pharmacyclics also notes there was "no significant difference in survival," a secondary endpoint. The firm plans to discuss the results with FDA; three trials looking at Xcytrin as a systemic therapy for relapsed lung cancer are ongoing...