FDA EXTENDS REVIEW PERIOD FOR GENTA'S GENASENSE NDA IN CLL

Genta announced that the FDA has notified the company that it has extended the review period for the pending new drug application (NDA) for Genasense (oblimersen sodium) Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has requested a meeting with FDA, and the company has submitted additional data analyses in support of the application. The FDA has indicated that submission of the new information comprises a major amendment to the NDA and has elected to extend the review period for 90 days to Jan. 29, 2007.

The Genasense NDA was reviewed at a meeting of the FDA's Oncologic Drug Advisory Committee meeting on Sept. 6 where it failed to receive a majority vote to recommend approval. The NDA was based on two separate clinical trials. The first was a Phase I/II trial that demonstrated the safety and activity of the drug used as a single-agent in 40 patients who had received extensive anti-leukemic therapy.

The second trial was a randomized, multicenter, multinational trial in which 241 patients with relapsed or refractory CLL received standard chemotherapy (fludarabine plus cyclophosphamide) with or without Genasense. The trial met its primary endpoint, which was the demonstration of a statistically significant increase in the proportion of patients who achieved complete or nodular partial remission.