The FDA Center for Drug Evaluation and Research (CDER) acknowledged that complete response, which was the primary endpoint in the pivotal trial, was an appropriate endpoint for assessing efficacy. FDA also agreed that this endpoint was achieved, and that those results supported the efficacy of the drug. However, CDER concluded that at present there was insufficient confirmatory evidence in the new drug application (NDA) to approve the drug.
The CDER has recommended two alternatives for exploring the efficacy of Genasense that could provide such confirmatory evidence. One option is to conduct an additional clinical trial. The other option is to collect additional information regarding the clinical course and progression of disease in patients from the previous pivotal trial in order to ascertain whether those data contain sufficient confirmatory evidence. The company currently plans to pursue both of these options.
Loretta Itri, Genta’s president, pharmaceutical development, and chief medical officer, said: “In parallel with collection and analysis of existing data in chronic lymphocytic leukemia (CLL), Genta has developed a new clinical trial, and the company will file its draft protocol seeking formal scientific advice at the May, 2008 meeting of the European Medicines Agency (EMEA).”