FDA Approves Genta's New Cancer Drug

 

Updated from 1:35 p.m. EDT

The Food and Drug Administration has approved the first commercial product from Genta(GNTA Quote), 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.

But Genta and Aventis(AVE Quote) said there were enough positive results to merit continuing their efforts to secure FDA approval, pending follow-up results for the skin cancer tests.

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