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FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy
The U. S. Food and Drug Administration (FDA) today expanded the approved use of Herceptin, a biological cancer drug. The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy). FDA granted priority review to the supplemental application for Herceptin.

Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, FDA approved Herceptin for the treatment of metastatic breast cancer (cancer that has spread to other sites in the body). Today’s approval expands its use to women with cancer only in the breast or lymph nodes which has been removed with surgery. Herceptin should only be prescribed for women diagnosed with HER2 positive breast cancer.

“This is especially good news for women who have breast cancer caused by excessive amounts of the HER-2 protein because this cancer typically has a poor prognosis,” said Dr. Steven Galson, Director for FDA’s Center for Drug Evaluation and Research.

The two studies leading to this new approved indication were conducted by the National Cancer Institute-sponsored Cooperative Groups, a multicenter clinical trials group. Patients in both trials received standard chemotherapy after surgery for breast cancer; approximately half the patients were also given Herceptin. The results from both trials, which included information on nearly 4,000 women, were combined and analyzed in 2005.

Due to positive results, the National Cancer Institute, a part of the National Institutes of Health, ended the studies early. The results showed that women who received Herceptin combined with chemotherapy had fewer relapses (return of breast cancer) for up to three years after surgery. The estimated three-year disease-free rates were 87 percent in women receiving Herceptin and chemotherapy and 75 percent in those receiving chemotherapy alone. It is too soon to know whether Herceptin combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer.

In the United States there are an estimated 212, 920 new cases of breast cancer and about 40,970 related deaths each year. Approximately 25 percent of women with breast cancer will have tumors that produce excessive amounts of HER2 protein.

The most serious side effect of Herceptin is heart failure (weakening of the heart muscle) that requires medical treatment. Due to the risk of heart disease, only certain patients should receive the drug, including:

Only patients whose tumors are HER2 Positive
Patients who do not have heart failure or weak heart muscle (cardiomyopathy). Patients must be screened for heart function before beginning and during Herceptin treatment.
Less common but serious side effects include infusion reactions (chills, fever, shortness of breath) that rarely are accompanied by lung problems, low white blood counts, and low red blood cell counts.

Herceptin (trastuzumab) is manufactured by Genentech, Inc, San Francisco, CA

http://lookstare.com/blog/index.php/Health?cat=33

FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy
The U. S. Food and Drug Administration (FDA) today expanded the approved use of Herceptin, a biological cancer drug. The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy). FDA granted priority review to the supplemental application for Herceptin.

Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, FDA approved Herceptin for the treatment of metastatic breast cancer (cancer that has spread to other sites in the body). Today’s approval expands its use to women with cancer only in the breast or lymph nodes which has been removed with surgery. Herceptin should only be prescribed for women diagnosed with HER2 positive breast cancer.

“This is especially good news for women who have breast cancer caused by excessive amounts of the HER-2 protein because this cancer typically has a poor prognosis,” said Dr. Steven Galson, Director for FDA’s Center for Drug Evaluation and Research.

The two studies leading to this new approved indication were conducted by the National Cancer Institute-sponsored Cooperative Groups, a multicenter clinical trials group. Patients in both trials received standard chemotherapy after surgery for breast cancer; approximately half the patients were also given Herceptin. The results from both trials, which included information on nearly 4,000 women, were combined and analyzed in 2005.

Due to positive results, the National Cancer Institute, a part of the National Institutes of Health, ended the studies early. The results showed that women who received Herceptin combined with chemotherapy had fewer relapses (return of breast cancer) for up to three years after surgery. The estimated three-year disease-free rates were 87 percent in women receiving Herceptin and chemotherapy and 75 percent in those receiving chemotherapy alone. It is too soon to know whether Herceptin combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer.

In the United States there are an estimated 212, 920 new cases of breast cancer and about 40,970 related deaths each year. Approximately 25 percent of women with breast cancer will have tumors that produce excessive amounts of HER2 protein.

The most serious side effect of Herceptin is heart failure (weakening of the heart muscle) that requires medical treatment. Due to the risk of heart disease, only certain patients should receive the drug, including:

Only patients whose tumors are HER2 Positive
Patients who do not have heart failure or weak heart muscle (cardiomyopathy). Patients must be screened for heart function before beginning and during Herceptin treatment.
Less common but serious side effects include infusion reactions (chills, fever, shortness of breath) that rarely are accompanied by lung problems, low white blood counts, and low red blood cell counts.

Herceptin (trastuzumab) is manufactured by Genentech, Inc, San Francisco, CA

http://lookstare.com/blog/index.php/Health?cat=33

FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy
The U. S. Food and Drug Administration (FDA) today expanded the approved use of Herceptin, a biological cancer drug. The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy). FDA granted priority review to the supplemental application for Herceptin.

Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, FDA approved Herceptin for the treatment of metastatic breast cancer (cancer that has spread to other sites in the body). Today’s approval expands its use to women with cancer only in the breast or lymph nodes which has been removed with surgery. Herceptin should only be prescribed for women diagnosed with HER2 positive breast cancer.

“This is especially good news for women who have breast cancer caused by excessive amounts of the HER-2 protein because this cancer typically has a poor prognosis,” said Dr. Steven Galson, Director for FDA’s Center for Drug Evaluation and Research.

The two studies leading to this new approved indication were conducted by the National Cancer Institute-sponsored Cooperative Groups, a multicenter clinical trials group. Patients in both trials received standard chemotherapy after surgery for breast cancer; approximately half the patients were also given Herceptin. The results from both trials, which included information on nearly 4,000 women, were combined and analyzed in 2005.

Due to positive results, the National Cancer Institute, a part of the National Institutes of Health, ended the studies early. The results showed that women who received Herceptin combined with chemotherapy had fewer relapses (return of breast cancer) for up to three years after surgery. The estimated three-year disease-free rates were 87 percent in women receiving Herceptin and chemotherapy and 75 percent in those receiving chemotherapy alone. It is too soon to know whether Herceptin combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer.

In the United States there are an estimated 212, 920 new cases of breast cancer and about 40,970 related deaths each year. Approximately 25 percent of women with breast cancer will have tumors that produce excessive amounts of HER2 protein.

The most serious side effect of Herceptin is heart failure (weakening of the heart muscle) that requires medical treatment. Due to the risk of heart disease, only certain patients should receive the drug, including:

Only patients whose tumors are HER2 Positive
Patients who do not have heart failure or weak heart muscle (cardiomyopathy). Patients must be screened for heart function before beginning and during Herceptin treatment.
Less common but serious side effects include infusion reactions (chills, fever, shortness of breath) that rarely are accompanied by lung problems, low white blood counts, and low red blood cell counts.

Herceptin (trastuzumab) is manufactured by Genentech, Inc, San Francisco, CA

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Acetaminophen Recalled Due to Metal Contamination

The Food and Drug Administration has issued a recall warning on 11 million bottles of acetaminophen. According to the Food and Drug Administration News site, Perrigo Company (Perrigo) voluntarily made the recall of the acetaminophen bottles because they contain small metal fragments. The 383 lots of the pain reliever were manufactured by Perrigo to be delivered under the label of various store-brands. According to the FDA News site, the small metal fragments affect only the 500mg caplets that were produced by this drug manufacturer.

The list of batches affected by metal contamination can be found at the FDA’s site at www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. Also, consumers who are worried that they might be in possession of the acetaminophen in question should locate the batch number that is printed on the container label. In addition, you may find a list of the store-brands that have been potentially affected by this recall by visiting the FDA’s site at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.

According to an Associated Press report, “Perrigo bills itself as the world’s largest manufacturer of store-brand nonprescription drugs.” An attempt from my part to reach Perrigo to get detailed information on which particular states were affected was unsuccessful. Associated Press, the FDA or Perrigo has released no information about which particular states are affected by this recall.

No injuries have been reported, and no adverse effect resulting from the consumption of these pills is anticipated, except perhaps “minor stomach discomfort and/or possible cuts to the mouth or throat.” according to FDA experts.

http://lookstare.com/blog/index.php/Health?cat=33

Acetaminophen Recalled Due to Metal Contamination

The Food and Drug Administration has issued a recall warning on 11 million bottles of acetaminophen. According to the Food and Drug Administration News site, Perrigo Company (Perrigo) voluntarily made the recall of the acetaminophen bottles because they contain small metal fragments. The 383 lots of the pain reliever were manufactured by Perrigo to be delivered under the label of various store-brands. According to the FDA News site, the small metal fragments affect only the 500mg caplets that were produced by this drug manufacturer.

The list of batches affected by metal contamination can be found at the FDA’s site at www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. Also, consumers who are worried that they might be in possession of the acetaminophen in question should locate the batch number that is printed on the container label. In addition, you may find a list of the store-brands that have been potentially affected by this recall by visiting the FDA’s site at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.

According to an Associated Press report, “Perrigo bills itself as the world’s largest manufacturer of store-brand nonprescription drugs.” An attempt from my part to reach Perrigo to get detailed information on which particular states were affected was unsuccessful. Associated Press, the FDA or Perrigo has released no information about which particular states are affected by this recall.

No injuries have been reported, and no adverse effect resulting from the consumption of these pills is anticipated, except perhaps “minor stomach discomfort and/or possible cuts to the mouth or throat.” according to FDA experts.