First Drug Approved for Pre-Surgery

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The U.S. Food and Drug Administration announced the approval for the first ever pre-surgical drug for breast cancer on Sept. 30. Perjeta, which was approved for late-stage HER2-positive patients in 2012, will now be available for patients with early stage breast cancer before undergoing surgery, according to a statement released by the FDA.

The drug is intended for use by people with HER2-positive, locally advanced, inflammatory or early stage breast cancer who are under high risk of their cancer spreading or returning. A recent study showed the use of the drug increased the probability of being cancer-free after 12 weeks of use.

“We are seeing a significant shift in the treatment paradigm for early stage breast cancer,” 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. “By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.”

Participants in a confirmatory trial for the accelerated approval of Perjeta all have HER2-positive cancer. The roughly 4,800 participants are at a high risk of their cancer returning. Results of this long-term study are expected by 2016.

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