FDA Approves First Pre-Surgical Drug for Treatment of Breast Cancer
(NEW YORK) — The U.S. Food and Drug Administration granted approval on Monday to the first pre-surgery drug for the treatment of breast cancer.
The drug, Perjeta, was previously approved in 2012 for treatment of advanced or late-stage HER2-positive breast cancer, the type of breast cancer with increased amount of the HER2 protein, which contributes to cancer cell growth and survival. Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said in a statement on Monday that “by making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.”
The approval for Perjeta comes after an FDA study in which 417 participants were assigned to receive one of four treatments, including Perjeta and/or two other cancer drugs. Nearly 40 percent of participants receiving all three drugs reached a stage defined as the absence of invasive cancer. Comparatively, just 21 percent receiving the other two drugs — but not Perjeta — reached the same stage of recovery.
The most common side effects of the now-approved treatment include hair loss, diarrhea, nausea and a decrease in white blood cells.
Breast cancer is the second-leading cause of cancer-related death among women. The FDA estimates 232,340 women will be diagnosed with the disease in 2013 and 39,620 will die of the disease this year. About 20 percent of breast cancers are considered HER2-positive.
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