2006 > FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy
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`This press release was updated December 12, 2006, to include regional lymph nodes as part of the approval.
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`FDA NEWS RELEASE
`FOR IMMEDIATE RELEASE
`P06-188
`November 16, 2006
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`Susan Cruzan, 301-827-6242
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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 in the breast and regional lymph nodes, which have 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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`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108788.htm[1/19/2015 4:34:12 PM]
`
`IMMUNOGEN 2180, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`2006 > FDA Expands Use of Herceptin for Early Stage Breast Cancer After Primary Therapy
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`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108788.htm[1/19/2015 4:34:12 PM]
`
`IMMUNOGEN 2180, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`