PHARMACYCLICS SUBMITS APPLICATION FOR METASTASES TREATMENT

Pharmacyclics Dec. 22 announced that it has submitted a New Drug Application (NDA) for Xcytrin Injection with the FDA. The company is seeking approval to market Xcytrin for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (i.e., cancer that has spread to the brain from another part of the body).

The NDA data packet includes efficacy and tolerability data from two Phase III randomized, controlled trials involving 805 patients, which compared the safety and efficacy of whole brain radiation therapy (WBRT) alone with WBRT plus Xcytrin. These studies utilized an innovative clinical benefit endpoint that measured neurologic outcomes.

Pharmacyclics is developing Xcytrin (motexafin gadolinium) as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). 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.

Xcytrin has been granted Fast Track designation by the FDA for use in the treatment of lung cancer brain metastases. This designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition.