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FDA Approves Genta's New Cancer Drug

The stock jumps on the news.

Updated from 1:35 p.m. EDT

The Food and Drug Administration has approved the first commercial product from

Genta

(GNTA)

, a biotechnology company specializing in cancer treatments.

The drug is Ganite, which will be used for cancer patients who develop a potentially lethal elevation of calcium in their blood. Genta, based in Berkeley Heights, N.J., said this disease -- called cancer-related hypercalcemia -- can occur in half the patients who have advanced cancer usually in the lung, breast, head, neck and kidney. The increase in calcium in the blood is provoked by tumor cells causing the loss of calcium from bones.

Genta closed at $14.89, up 38 cents, or 2.6%. The stock had climbed as high as $15.45.

Ganite hasn't received as much attention or commanded as much controversy as Genta's experimental drug Genasense for several types of cancer. Last week, the company and its partner released test results on Genasense's effect, when combined with chemotherapy, on advanced melanoma, the most dangerous form of skin cancer.

The results of these phase III trials -- the last step before the FDA considers a drug for marketing -- showed Genasense failed to meet its primary goal of achieving a statistically significant increase in patient survival rates.

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But Genta and

Aventis

(AVE)

said there were enough positive results to merit continuing their efforts to secure FDA approval, pending follow-up results for the skin cancer tests.

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.