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`Press Announcements > FDA approves new treatment for latestage breast cancer
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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`FDA NEWS RELEASE
`For Immediate Release: Feb. 22, 2013
`Media Inquiries: Stephanie Yao, 3017960394, stephanie.yao@fda.hhs.gov
`(mailto:stephanie.yao@fda.hhs.gov)
`Consumer Inquiries: 888INFOFDA
`
`FDA approves new treatment for latestage breast cancer
`
`En Español (/NewsEvents/Newsroom/ComunicadosdePrensa/ucm341213.htm)
`
`The U.S. Food and Drug Administration today approved Kadcyla (adotrastuzumab emtansine), a new
`therapy for patients with HER2positive, latestage (metastatic) breast cancer.
`
`HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of
`cancer cells (HER2positive), including some breast cancers. In these HER2positive breast cancers,
`the increased amount of the HER2 protein contributes to cancer cell growth and survival.
`
`Kadcyla is intended for patients who were previously treated with trastuzumab, another antiHER2
`therapy, and taxanes, a class of chemotherapy drugs commonly used for the treatment of breast
`cancer.
`
`“Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth,” said
`Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s
`Center for Drug Evaluation and Research. “Kadcyla delivers the drug to the cancer site to shrink the
`tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the
`HER2 protein.”
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`Referred to as TDM1 during clinical research, Kadcyla was reviewed under the FDA’s priority review
`program, which provides for an expedited sixmonth review of drugs that may provide safe and
`effective therapy when no satisfactory alternative therapy exists, or offer significant improvement
`compared to marketed products. Other FDAapproved drugs used to treat HER2positive breast
`cancer include trastuzumab (1998), lapatinib (2007) and pertuzumab (2012).
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`The safety and effectiveness of Kadcyla were evaluated in a clinical study of 991 patients randomly
`assigned to receive Kadcyla or lapatinib plus capecitabine, another chemotherapy drug. Patients
`received treatment until either the cancer progressed or the side effects became intolerable. The study
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`Press Announcements > FDA approves new treatment for latestage breast cancer
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`was designed to measure progressionfree survival, the length of time patients lived without the cancer
`progressing, and overall survival, the length of time patients lived before death.
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`Results showed that patients treated with Kadcyla had a median progressionfree survival of 9.6
`months compared to 6.4 months in patients treated with lapatinib plus capecitabine. The median
`overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus
`capecitabine group.
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`Kadcyla is being approved with a Boxed Warning alerting patients and health care professionals that
`the drug can cause liver toxicity, heart toxicity and death. The drug can also cause severe life
`threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla treatment.
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`The most common side effects reported in patients treated with Kadcyla were nausea, fatigue, pain in
`the muscles or joints, low levels of platelets in the blood (thrombocytopenia), increased levels of liver
`enzymes, headache, and constipation.
`
`Breast cancer (http://www.cancer.gov/cancertopics/types/breast) is the second leading cause
`of cancerrelated death among women. An estimated 232,340 women will be diagnosed with breast
`cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute.
`Almost 20 percent of breast cancers have increased amounts of the HER2 protein.
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`Kadcyla, trastuzumab and pertuzumab are marketed by South San Francisco, Calif.based
`Genentech, a member of the Roche Group. Lapatinib is marketed by GlaxoSmithKline, based in
`Research Triangle Park, N.C.
`
`For more information:
`
`FDA: Office of Hematology and Oncology Products
`(/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm091745.htm)
`
`FDA: Approved Drugs: Questions and Answers
`(/Drugs/ResourcesForYou/Consumers/ucm054420.htm)
`
`FDA: Drug Innovation
`(http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm)
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`NCI: Breast Cancer (http://www.cancer.gov/cancertopics/types/breast)
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`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public
`health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and
`other biological products for human use, and medical devices. The agency also is responsible for the
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