Pharmacyclics to file Xcytrin "over protest"

California, USA-based drugmaker Pharmacyclics says it has requested that the Food and Drug Administration accept the New Drug Application for its anticancer drug Xcytrin (motexafin gadolinium), under the agency's "file over protest" procedure. The FDA rejected the original NDA on the basis that the data did not demonstrate statistically-significant differences between treatment arms in a Phase III efficacy trial (Marketletter February 26).

Pharmacyclics explained that it had decided to use the "file over protest" procedure, which allows sponsors to have their NDA filed and reviewed when there is a disagreement over its acceptability, because it believes that the clinical data merits a "complete and thorough review" by a panel of experts.

According to the regulations, the new filing date will be on, or about April 30, 60 days after the company requested a meeting to discuss the refuse to file letter. The agency then has either four months, for priority cases, or eight months, under the more standard protocol, to complete its consideration of the drug, although there is no assurance that the NDA will be approved or that an advisory panel will meet to examine the data.