PHARMACYCLICS TO SUBMIT NEW DRUG APPLICATION FOR XCYTRIN

Pharmacyclics will submit a new drug application (NDA) to the FDA to market Xcytrin (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (i.e., lung cancer that has spread to the brain from another part of the body).

New data from a late-stage trial, called the SMART trial, will be included in the application. The data showed, according to a presentation that will be made at an upcoming conference, that Xcytrin combined with prompt whole brain radiation therapy prolongs time to neurologic progression of the lung cancer.