Xcytrin has been developed to treat non-small cell lung cancer (NSCLC) patients with brain metastases. In December 2006, Pharmacyclics sought marketing approval for Xcytrin in combination with radiation therapy for the treatment of brain metastases from NSCLC. In February 2007, the company received a refuse to file letter from the FDA, stating that the clinical trials did not show that the drug was significantly better than placebo.
The company then filed the NDA over protest, a procedure permitted by regulation that allows sponsors to have their NDA filed and reviewed when there is disagreement over the acceptability of the NDA. There can be no assurance that the NDA will be approved or that there will be an advisory panel meeting to review the data.
Richard Miller, president and CEO of Pharmacyclics, said: “We and our investigators, outside experts and patient advocates believe our data support the efficacy and safety of Xcytrin for the treatment of brain metastases for patients with non-small cell lung cancer and justify a comprehensive review by the agency.”
According to the National Cancer Institute, over 200,000 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% of lung cancer patients. No drug has ever been shown to provide neurologic benefit to these patients.