RxTrials Institute Drug Pipeline Alert

CDER has decided available data are not adequate to support approval of Genta’s Genasense for patients with relapsed or refractory chronic lymphocytic leukemia.

The decision comes in response to an appeal filed by Genta last October. CDER acknowledged that the primary endpoint in the trial was appropriate for assessing efficacy. However, it concluded that there was insufficient confirmatory evidence in the NDA to approve Genasense (oblimersen sodium).

CDER recommended two alternatives for exploring the efficacy of Genasense — conducting an additional clinical trial or collecting more information regarding the clinical course and progression of disease in patients from the previous trial. Genta said it plans to pursue both of these options.

In the previous trial, 241 patients with relapsed or refractory CLL were randomly assigned to receive Flu/Cy with or without Genasense. The study achieved its primary endpoint — the complete elimination of all clinical signs of leukemia and its related symptoms.