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`Press Announcements > FDA approves Perjeta for neoadjuvant breast cancer treatment
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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`FDA NEWS RELEASE
`For Immediate Release: Sept. 30, 2013
`Media Inquiries: Stephanie Yao, 3017960394, stephanie.yao@fda.hhs.gov
`(mailto:stephanie.yao@fda.hhs.gov)
`Consumer Inquiries: 888INFOFDA
`
`En Español (/NewsEvents/Newsroom/ComunicadosdePrensa/ucm375268.htm)
`
`FDA approves Perjeta for neoadjuvant breast cancer treatment
`First drug approved for use in preoperative breast cancer
`
`The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab)
`as part of a complete treatment regimen for patients with early stage breast cancer before surgery
`(neoadjuvant setting). Perjeta is the first FDAapproved drug for the neoadjuvant treatment of breast
`cancer.
`
`Perjeta was approved in 2012 for the treatment of patients with advanced or latestage (metastatic)
`HER2positive breast cancer. HER2positive breast cancers have increased amounts of the HER2
`protein that contributes to cancer cell growth and survival.
`
`Perjeta’s new use is intended for patients with HER2positive, locally advanced, inflammatory or early
`stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at
`high risk of having their cancer return or spread (metastasize) or of dying from the disease. It is to be
`used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon
`the treatment regimen used, may be followed by chemotherapy after surgery. Following surgery,
`patients should continue to receive trastuzumab to complete one year of treatment.
`
`“We are seeing a significant shift in the treatment paradigm for early stage breast cancer,” said
`Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s
`Center for Drug Evaluation and Research. “By making effective therapies available to highrisk
`patients in the earliest disease setting, we may delay or prevent cancer recurrences.’’
`
`In May 2012, the FDA issued a draft guidance
`(/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf)
`about the use of pathologic complete response (pCR), defined as the absence of invasive cancer in
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`Press Announcements > FDA approves Perjeta for neoadjuvant breast cancer treatment
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`the breast and lymph nodes, as an endpoint to support accelerated approval of a drug for neoadjuvant
`treatment of highrisk, early stage breast cancer. Under the FDA’s accelerated approval program,
`patients are provided access to promising drugs to treat serious or lifethreatening conditions while
`confirmatory clinical trials are conducted.
`
`Perjeta’s accelerated approval for neoadjuvant treatment is based on a study designed to measure
`pCR. In the study, 417 participants were randomly assigned to receive one of four neoadjuvant
`treatment regimens: trastuzumab plus docetaxel, Perjeta plus trastuzumab and docetaxel, Perjeta plus
`trastuzumab or Perjeta plus docetaxel. About 39 percent of participants who received Perjeta plus
`trastuzumab and docetaxel achieved pCR, compared to about 21 percent who received trastuzumab
`plus docetaxel.
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`The confirmatory trial for this accelerated approval is being conducted in participants with HER2
`positive breast cancer who had prior breast cancer surgery and are at high risk of having their cancer
`return. More than 4,800 participants are enrolled in this trial, which will provide further data on efficacy,
`safety and longterm outcomes. Results are expected in 2016.
`
`The most common side effects reported in participants receiving Perjeta plus trastuzumab and
`docetaxel were hair loss, diarrhea, nausea and a decrease in infectionfighting white blood cells.
`Other significant side effects included decreased cardiac function, infusionrelated reactions,
`hypersensitivity reactions and anaphylaxis.
`
`The FDA reviewed Perjeta’s use for neoadjuvant treatment under the agency’s priority review
`program, which provides for an expedited review of drugs that may offer major advances in treatment.
`
`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.
`
`Perjeta is marketed by Genentech, a member of the Roche Group, based in South San Francisco,
`Calif.
`
`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)
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`Press Announcements > FDA approves Perjeta for neoadjuvant breast cancer treatment
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`NCI: Breast Cancer (http://www.cancer.gov/cancertopics/types/breast)
`
`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
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