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First Drug Approved for Preoperative Breast Cancer Treatment

By BiotechDaily International staff writers
Posted on 09 Oct 2013
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The US Food and Drug Administration (FDA) has now granted accelerated approval for a drug to be used for high-risk patients with early stage breast cancer in a neoadjuvant setting.

Perjeta (pertuzumab), marketed by Genentech (South San Francisco, CA, USA), a member of the Roche Group, was approved in 2012 for patients with advanced or late-stage (metastatic) HER2-positive breast cancer. Approximately 20% of breast cancers have increased amounts of the HER2 protein. Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) that are at high risk of having their cancer return or metastasize, or of dying from the disease. It is to be used as part of a complete treatment regimen, in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon the treatment regimen, 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, MD, director of the Office of Hematology and Oncology Products, FDA Center for Drug Evaluation and Research. “By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.’’

In 2012 the FDA issued a draft guidance about the use of pathologic complete response (pCR; defined as the absence of invasive cancer in the breast and lymph nodes) as an endpoint to support accelerated approval of a drug for neoadjuvant treatment of high-risk, early stage breast cancer. Approval for Perjeta is based on a study designed to measure pCR where 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% of participants who received Perjeta plus trastuzumab and docetaxel achieved pCR, compared to about 21% who received trastuzumab plus docetaxel. The most common side effects reported in participants receiving Perjeta plus trastuzumab and docetaxel were hair loss, diarrhea, nausea, and a decrease in infection-fighting white blood cells. Other significant side effects included decreased cardiac function, infusion-related reactions, hypersensitivity reactions, and anaphylaxis.

The confirmatory trial for this accelerated approval is being conducted in a study of over 4,800 participants who had prior breast cancer surgery and are at high risk of having their cancer return. The results, expected in 2016, will provide further information on efficacy, safety, and long-term outcomes.

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US Food and Drug Administration

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