Pharmacyclics files Xcytrin with US FDA

US drugmaker Pharmacyclics says that the Food and Drug Administration has accepted its New Drug Application for Xcytrin (motexafin gadolinium) injection for the treatment of non-small cell lung cancer patients with brain metastases, setting a decision date for December 31, 2007.

No drug has ever been shown to provide neurologic benefit to these patients, the firm noted. The NDA submission was based on the results of two randomized Phase III trials and their integrated analysis. The first of these did not show a significant benefit overall but did demonstrate a clinically and statistically significant improvement in time-to-neurologic-progression in NSCLC. However, a follow-up pivotal 554-patient trial showed a 5.4 month improvement in time-to-progression, the primary pre-specified endpoint, with a median time-to-progression of 15.4 months for Xcytrin compared to 10.0 months for the control (p=0.12).