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Susan G. Komen Applauds FDA Approval of Perjeta® for People with HER2-Positive Early Stage Breast Cancer
Perjeta® regimen is the first FDA-approved drug for the treatment of breast cancer before surgery
WASHINGTON, D.C. – October 2, 2013 – Susan G. Komen® commends the U.S. Food and Drug Administration (FDA) for its accelerated approval on Monday of Perjeta® (pertuzumab) as part of neoadjuvant treatment (use before surgery) for people with HER2-positive early-stage breast cancer 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 as part of a complete treatment regimen for early-stage breast cancer.
Perjeta® is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. It is designed specifically to prevent the HER2 receptor from pairing with other HER receptors, a process that is believed to play a role in tumor growth and survival. Previously, the drug had been used for treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer.
In addition to being the first breast cancer drug approved for use in the neoadjuvant setting, Perjeta® is also the first to receive accelerated approval based on a trial that measured pCR (pathological complete response). The study found that a higher percentage of patients who received the combination of Perjeta®, trastuzumab and docetaxel chemotherapy prior to surgery had no evidence of tumor tissue detectable at the time of surgery (i.e., achieved pCR).
“This marks a milestone for the approval of drugs for the neoadjuvant treatment of early-stage breast cancer, and we applaud the FDA for using this pathway to provide women with high-risk, early stage disease access to promising drugs that may prevent or delay breast cancer recurrences, while confirmatory clinical trials are conducted.” said Chandini Portteus, chief mission officer for Susan G. Komen.