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Roche Holding AG Announces FDA Grants Genentech’s Perjeta Accelerated Approval For Use Before Surgery In People With HER2 Positive Early Stage Breast Cancer


Monday, 30 Sep 2013 12:30pm EDT 

Roche Holding AG announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40% of people receiving the combination of Perjeta, Herceptin (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or PCR). 

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36.84
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