FDA FINDS PHARMACYCLICS' XCYTRIN NDA TO BE INCOMPLETE

Pharmacyclics announced it has received a refuse-to-file letter from the FDA for the company's new drug application (NDA) for Xcytrin for the treatment of non-small-cell lung cancer patients with brain metastases.

In the letter, the FDA said that the company's application for Xcytrin (motexafin gadolinium) is not sufficiently complete to permit a substantive review. According to the FDA, the application is based on clinical studies that failed to demonstrate statistically significant differences between treatment arms in the primary endpoints.

"We will be evaluating our options with Xcytrin for the brain metastases indication and determine the best path forward," Richard Miller, president and CEO of Pharmacyclics, said. "Beyond this indication, the clinical development program with Xcytrin continues on multiple fronts. Several ongoing trials are evaluating Xcytrin in non-small-cell lung cancer and other cancers."

Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative-stress-related proteins. Its multifunctional mode of action provides the opportunity for Xcytrin to be used in a broad range of cancers, according to the company.