GNTA WASHINGTON The Food and Drug Administration said Tuesday that a proposed leukemia drug by Genta Inc. (GNTA) appears to temporarily work in some patients, but that so far it's not been shown to increase overall survival.
The Berkeley Heights, N.J., company is seeking FDA approval for its proposed drug, Genasense, to treat chronic lymphocytic leukemia, the most common form of adult leukemia, or blood cancer, in the U.S. The drug would be used in combination with two chemotherapy drugs and in patients who failed previous treatment with another drug.
A Food and Drug Administration panel is set to consider whether to recommend Genasense for use in leukemia patients Wednesday. The FDA typically follows its panels' advice but is not required to. The agency posted its review of Genasense on its Web site Tuesday as is customary the day before panel meetings.
Genta studied the drug in 241 patients, about half of whom received chemotherapy plus Genasense and the other half who received chemotherapy alone. All of the patients had failed treatment with other cancer drugs.
Like most other chemotherapy drugs which are designed to kill cancer cells, Genasense was administered intravenously. It's designed to block a protein that's believed to inhibit chemotherapy-induced cell death.
Overall, the study found that 20 out of 120 patients, or 16.7%, receiving Genasense and other therapy temporarily had their disease improve compared with 8 out of 121, or 6.6%.
The FDA agreed with the study findings. However, the FDA said overall survival among both patient groups was similar, lasting just less than three years. But, both the company and the FDA noted that no cancer drug has so far been shown to improve overall survival among such leukemia patients.
The agency also said adding Genasense to the treatment regimen didn't help women or patients older than 65 and that adding the drug "appears to add to the toxicity of the treatment."
However, Genta said, for certain patients, Genasense helped improve the quality of their lives by temporarily beating back the disease and that for patients who had a so-called complete response it lasted for an average of more than 22 months. Some of the study patients are still being followed.
In 2004, an FDA panel rejected Genasense as a proposed treatment for advanced melanoma, or skin cancer. The drug is currently being studied as a cancer treatment in other cancers including prostate and lung. |
