Pharmacyclics files cancer drug over protest

The application seeks approval to market the drug for the treatment of non-small cell lung cancer patients with brain metastases.

The company received a refuse to file letter from the FDA when it submitted a previous new drug application in February. The FDA claimed the application failed to demonstrate statistically significant differences between treatment arms in the primary endpoint of the study to support approval.

Pharmacyclics is taking this action to ensure that its new drug application receives a complete review. Pharmacyclics believes it can still secure market clearance for Xcytrin because there have been previous applications for oncology drugs that have been accepted for filing without meeting the primary endpoint with statistical significance. In some cases this has led to product approvals, particularly in cases where the unmet need is great, the drug is well tolerated and there are few if any other treatment options available.

“We strongly believe that the clinical data justify a complete and thorough review and that a panel of experts be given an opportunity to examine and evaluate the data,” said Richard Miller, president and CEO of Pharmacyclics.

According to Pharmacyclics, no drug or treatment has ever been shown to provide neurologic benefit to these patients.