FDA Approves Genta's New Cancer Drug

The companies said they missed their research goals because some patients had not been tested for a long enough period of time; in several months, they added, the results will give a better picture of whether Genasense would, indeed, meet the goals of the research. The companies said they expect to complete their Genasense application to the FDA by the end of the year.

The Genasense research report didn't change any analysts' opinions, according to Thomson First Call, which lists three research firms with strong buy recommendations and two with buy ratings.

As for Ganite, Genta said it will establish a patient assistance program to coincide with its marketing of the drug. "While we've previously supplied the drug to individual patients who failed to respond to conventional treatment, today's approval marks our transition from development to commercialization," said Bruce Williams, Genta's senior vice president for sales and marketing, in a prepared statement.

Genta's application to the FDA included a clinical trial that showed that 75% of patients receiving Ganite achieved normal blood calcium levels compared to 27% of patients receiving calcitonin, a traditional treatment.

Ganite was originally developed by the National Cancer Institute as a chemotherapy agent. Genta is now testing the efficacy of the drug in patients with certain types of non-Hodgkins lymphoma, a cancer of the lymphatic system.