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FDA Panel Rejects
Proposed Cancer Drug
By JENNIFER CORBETT DOOREN
September 6, 2006 12:31 p.m.
WASHINGTON -- A Food and Drug Administration panel said Wednesday a proposed leukemia drug by Genta Inc. didn't provide enough benefit to recommend that the agency approve the drug.
The outside panel of medical experts voted 7 to 3 against the proposed drug, Genasense. The panel specifically voted on a question that asked whether the drug demonstrated "substantial evidence of effectiveness." The FDA typically follows its panel's advice but is not required to do so. The agency is expected to make a final decision about Genasense by the end of October.
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.
The main clinical study of the drug showed that while it worked temporarily in some patients, that it did not improve overall survival, or the length of patient's lives.
Loretta Itri, Genta's chief medical officer, explained that Genasense is a drug designed to be used with chemotherapy drugs to enhance the effectiveness of chemotherapy. Genasense is designed to block a protein that's believed to inhibit chemotherapy-induced cell death.
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.
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%.
Richard Pazdur the FDA's director of the office of oncology products said the findings overall showed that adding Genasense provided a 10% benefit, which was short of the study goal of a 20% benefit. He noted that FDA regulations for approving cancer drugs require a drug to show "substantial" benefit.
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.
During the panel meeting, Genta representatives noted that 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.
The three panel members who voted in favor of the drug said it should be available and studied further to see who might benefit from the drug.