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Pharmacyclics Xcytrin NDA in late 2006

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pharmacyclics will submit an NDA for Xcytrin (motexafin gadolinium) for treatment of patients with brain metastases with non-small cell lung cancer, the firm announces May 9. The company claims that recent analyses of its failed Phase III SMART trial show that while overall results announced in December revealed no significant improvement in progression or survival, statistical significance was achieved in the study's North American subpopulation (1Pharmaceutical Approvals Monthly January 2006, In Brief). Pharmacyclics says it has discussed the findings with FDA. SMART (Study of Neurologic Progression with Motexafin Gadolinium & Radiation Therapy) will be presented at the American Society of Clinical Oncology meeting in Atlanta on June 3...

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