Breast cancer research treatment
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Agency U.S. Food and Drug Administration or FDA strictly prohibits the use of Avastin to treat breast cancer. According to the FDA, the benefits of these drugs is not worth the risks posed.
The FDA recommendation was decided after a meeting between the Center for Drug Evaluation and Research and Genentech (Avastin drug manufacturers).
"Although we have anecdotal information, but we have no evidence that the drug can prolong survival or improve quality of life," said Natalie Compagni-Portis, as well as patient representatives and voting members of the FDA panel.
In a series of four questions, the six panel members said that clinical trials conducted by Genentech did not provide evidence that Avastin can memperanjang life for breast cancer patients, also did not improve their quality of life. The panel also recommended to the FDA Commissioner Peggy Hamburg in order not to have to continue to recommend Avastin for breast cancer patients.
But the decision from the FDA is actually caused mainly cons of a number of patients and families of patients with breast cancer. The reason, they regard the use of Avastin actually has a lot of help and benefit to them.
Priscilla Howard, a breast cancer patient, has been using Avastin approximately two years and has seen a remarkable difference in the progression of the disease, that he put on the panel to the FDA in the first and second day of trial
"I want a weapon (Avastin) was still available when my fight against this devastating disease," Howard told the panel.
Previously, the FDA has approved use of Avastin in February 2008 to treat patients with end-stage breast cancer. Because allegedly the drug can slow disease progression and improve overall patient survival.
However, the results of four experiments performed, it is known that more than 3,000 women did not get significant changes in disease progression and no reduction in mortality among those who have been using Avastin and chemotherapy.
"Decisions should be based on the totality of evidence in all clinical trials. The data submitted to the FDA showed that Avastin is safe and effective for treating breast cancer" said Dr. Richard Pazdur, FDA Director of Oncology Drug Products, at a hearing Tuesday (29 / 6 / 2011), yesterday, as reported by the BBC.
Meanwhile, the experts who defended Genentech (the manufacturer of Avastin), indicating that the combination of Avastin with paclitaxel chemotherapy can benefit a lot for giving out patient.
"We are very disappointed with the FDA's recommendation and hope that the Commissioner did not decide to remove this drug. Avastin for women to be so, because there are very few treatment options for breast cancer," said Genentech.
Hanna crystal, (35), a mother with breast cancer said that he believed that he would not be alive today if not for Avastin. Hanna gets a verdict with breast cancer stage 4 (four) in July 2010 ago said that the cancer does not develop, and until recently he was still using Avastin.
"I have a lot of hope for life. I am here to plead with them (FDA) to grant mercy for our lives, "he said.
However, the results of the FDA study found no overall benefit of the drug. Even the FDA claims that Avastin may increase risk of death to the patient, because in some ways the drug-containing toxic (poison).
"There is no evidence that Avastin save or prolong life," said Dr. Patricia Keegan, director of FDA's Division of Biologic Oncology Products.
The FDA recommendation was decided after a meeting between the Center for Drug Evaluation and Research and Genentech (Avastin drug manufacturers).
"Although we have anecdotal information, but we have no evidence that the drug can prolong survival or improve quality of life," said Natalie Compagni-Portis, as well as patient representatives and voting members of the FDA panel.
In a series of four questions, the six panel members said that clinical trials conducted by Genentech did not provide evidence that Avastin can memperanjang life for breast cancer patients, also did not improve their quality of life. The panel also recommended to the FDA Commissioner Peggy Hamburg in order not to have to continue to recommend Avastin for breast cancer patients.
But the decision from the FDA is actually caused mainly cons of a number of patients and families of patients with breast cancer. The reason, they regard the use of Avastin actually has a lot of help and benefit to them.
Priscilla Howard, a breast cancer patient, has been using Avastin approximately two years and has seen a remarkable difference in the progression of the disease, that he put on the panel to the FDA in the first and second day of trial
"I want a weapon (Avastin) was still available when my fight against this devastating disease," Howard told the panel.
Previously, the FDA has approved use of Avastin in February 2008 to treat patients with end-stage breast cancer. Because allegedly the drug can slow disease progression and improve overall patient survival.
However, the results of four experiments performed, it is known that more than 3,000 women did not get significant changes in disease progression and no reduction in mortality among those who have been using Avastin and chemotherapy.
"Decisions should be based on the totality of evidence in all clinical trials. The data submitted to the FDA showed that Avastin is safe and effective for treating breast cancer" said Dr. Richard Pazdur, FDA Director of Oncology Drug Products, at a hearing Tuesday (29 / 6 / 2011), yesterday, as reported by the BBC.
Meanwhile, the experts who defended Genentech (the manufacturer of Avastin), indicating that the combination of Avastin with paclitaxel chemotherapy can benefit a lot for giving out patient.
"We are very disappointed with the FDA's recommendation and hope that the Commissioner did not decide to remove this drug. Avastin for women to be so, because there are very few treatment options for breast cancer," said Genentech.
Hanna crystal, (35), a mother with breast cancer said that he believed that he would not be alive today if not for Avastin. Hanna gets a verdict with breast cancer stage 4 (four) in July 2010 ago said that the cancer does not develop, and until recently he was still using Avastin.
"I have a lot of hope for life. I am here to plead with them (FDA) to grant mercy for our lives, "he said.
However, the results of the FDA study found no overall benefit of the drug. Even the FDA claims that Avastin may increase risk of death to the patient, because in some ways the drug-containing toxic (poison).
"There is no evidence that Avastin save or prolong life," said Dr. Patricia Keegan, director of FDA's Division of Biologic Oncology Products.
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