LCA Supports Re-review of New Drug for Brain Metastases

April 5, 2007-- Recently the Food and Drug Administration turned down the application for approval of a new drug for brain metastases which some lung cancer patients may face. In fact, more brain cancer is caused by metastases from other body sites than by primary tumors. Currently the only treatment is radiation. The FDA was not impressed by the trial results of a potential new drug called Xcytrin, developed by Pharmacyclics. The company claimed the FDA decision was not warranted by the facts and presented convincing evidence that Xcytrin could be helpful in stemming the progression of brain tumors. In a letter sent out today to the Director of Oncology Drug Products at FDA,  LCA President Laurie Fenton said this is "the first drug ever shown to provide a neurologic benefit for patients with brain metastases. Given the critical importance of new treatments in this long-neglected area, LCA urges that all the data be carefully reviewed in its totality and with all due haste."

View Letter (pdf)