FDAnews Drug Daily Bulletin

The FDA has decided the available data for leukemia drug Genesense are not adequate to support approval of the drug, which is designed for relapsed or refractory chronic lymphocytic leukemia.

In response to an appeal filed by drugmaker Genta last October, the Center for Drug Evaluation and Research acknowledged the primary endpoint in the pivotal trial was appropriate for assessing efficacy, Genta said. The FDA also agreed that this endpoint was achieved and that those results supported the efficacy of the drug. However, CDER concluded there was insufficient confirmatory evidence in the NDA to approve Genasense (oblimersen sodium).

The agency recommended two methods of providing confirmatory evidence for the drug, Genta said. One option is to conduct another clinical trial. The other is to collect additional information on patients from the previous pivotal trial and determine if those data contain sufficient confirmatory evidence. The company plans to pursue both of these options.