GENTA RESPONDS TO EMEA'S QUESTIONS ABOUT GENASENSE APPLICATION

Genta announced it has completed its response to the list of outstanding issues from the European Medicines Agency (EMEA) regarding its marketing authorization application (MAA) for Genasense (oblimersen sodium), its lead anticancer drug, for treatment of advanced melanoma. The company currently anticipates that the EMEA will complete its review and issue its opinion regarding approval within 90 days.

Genasense is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma, according to Genta.

The MAA is based on long-term data derived from the largest randomized, controlled trial ever conducted in patients with advanced melanoma. In the trial, which was conducted at 139 sites in nine countries, 771 patients were randomly assigned to receive chemotherapy with dacarbazine alone or in combination with Genasense. The submission includes data compiled after 24 months of follow-up.

In the U.S., Genta recently received an FDA not approvable letter for its new drug application for Genasense for treating chronic lymphocytic leukemia. In addition, a trial of Genasense conducted in older, previously untreated patients with acute myelogenous leukemia failed to meet its primary endpoint.