Pharmacyclics Inc. submitted a New Drug Application (NDA) for Xcytrin (motexafin gadolinium) Injection with the US Food and Drug Administration (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 3 randomised, controlled trials involving 805 patients, which compared the safety and efficacy of whole brain radiation therapy (WBRT) alone to WBRT plus Xcytrin. These studies utilized an innovative clinical benefit endpoint that measured neurologic outcomes.

"The clinical development program with Xcytrin continues on multiple fronts," said Richard A. Miller, MD, president and CEO of Pharmacyclics. "In addition to the completed trials in brain metastases, which form the basis of our NDA submission, several other ongoing trials are evaluating Xcytrin in non-small cell lung cancer and other cancers. We are also moving forward with several other novel compounds, which are in clinical and preclinical development."

According to the National Cancer Institute, over 170,000 patients will be diagnosed with lung cancer this year in the US. Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50 per cent of lung cancer patients. Spread of lung cancer to the brain may occur early in the course of disease or may be a later complication of this illness.

Brain metastases occur when cancer cells spread to the brain and grow, causing major neurologic complications. Patients with brain metastases usually suffer serious deterioration of neurologic and neurocognitive function such as loss of short-term memory, compromised verbal skills and fine motor coordination, and reduction in cognitive performance. Standard therapy for patients with brain metastases from lung cancer involves the prompt use of cranial radiation, which is used to prevent neurological deterioration and improve neurologic outcomes.

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumours 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.