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FDA Approves First 'Pre-Surgical' Drug for Breast Cancer

Perjeta, which seems to shrink early-stage tumors, can now be used before surgery

WebMD News from HealthDay

By Margaret Farley Steele

HealthDay Reporter

MONDAY, Sept. 30 (HealthDay News) -- The U.S. Food and Drug Administration on Monday approved the first drug to be used before the surgical treatment of breast cancer.

Perjeta (pertuzumab), which was granted accelerated approval by the FDA, is already used to treat breast cancer in its advanced stages. This is the first time that women with early-stage HER2-positive breast cancers -- a typically aggressive form of tumor -- will have the chance to start treatment with something other than surgery, the agency said.

The hope is that pre-surgical treatment could result in less invasive surgeries and improved survival rates. Typically, surgery has been the first step in breast cancer treatment.

"We are seeing a significant shift in the treatment paradigm for early-stage breast cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an agency statement released Monday. "By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.''

An FDA advisory panel had voted unanimously earlier this month to recommend approval of broader use of the drug. An agency report had said the drug looked promising in trials, but added that drug-related cardiac concerns required additional research.

Perjeta is made by Roche Group's Genentech division; accelerated approvals usually are given to drugs that haven't been thoroughly tested but show promising results in early trials.

Members of the advisory panel that voted on Perjeta earlier this month had insisted at the time that Genentech carry out more trials to ensure the drug will enable breast cancer patients to live longer, healthier lives.

At the time, cancer specialists welcomed the news.

"This is tremendously exciting," said Dr. Amy Tiersten, associate professor in the division of hematology and medical oncology at Mount Sinai Medical Center in New York City.

"Pertuzumab was FDA approved in 2012 for the treatment of metastatic breast cancer when it was shown that it improved survival when added to standard regimens for HER2-positive metastatic breast cancer," Tiersten said. Metastatic breast cancer is cancer that has spread to other parts of the body.

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