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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


"But the really exciting information is when this can be translated into earlier stages of disease, where we can completely eradicate the disease and cure more women," she said.

The trial the panel vote was based on showed that when Perjeta was added to standard pre-surgical regimens for HER2-positive breast cancer, the chance of finding no cancer after the treatment was nearly doubled, Tiersten said.

Women who have chemotherapy before surgery and who achieve complete remission -- no cancer at the time of breast surgery -- have a much greater chance of being completely cured of their disease, she said.

Dr. Aye Moe Thu Ma, an attending physician in breast surgical oncology with St. Luke's and Roosevelt Hospitals in New York City, also voiced enthusiasm at the time.

"We currently have limited options for [first-step] treatment of breast cancer," Ma said. "I'm excited that this may provide a more specific treatment for people with HER2-positive cancer."

This means women may be able to keep their breasts because the tumor size is reduced before surgery, and some women may prefer this, she added.

Both short- and long-term side effects will need to be examined to fully evaluate risks and benefits of this medication if it is approved, Ma added.

Perjeta is one of many newer biologic agents used to treat breast cancer. "These biologic, or 'targeted,' treatments work on breast cancer cells in a more specific way than some older treatments, so there are many fewer casualties to normal cells, translating into many fewer side effects for our patients," Tiersten explained.

More than 4,800 women are enrolled in a "confirmatory" trial that will provide further data on efficacy, safety and long-term outcomes, the FDA said. Those results are expected in 2016, according to the agency.

About one in eight women in the United States will develop breast cancer in her lifetime.

According to the Mayo Clinic, HER2-positive breast cancer is a breast cancer driven by a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.

HER2-positive breast cancers typically are more aggressive than other types of breast cancer. But there are effective drug treatments, including trastuzumab (Herceptin) and lapatinib (Tykerb). Both drugs can produce side effects, including congestive heart failure, according to the Mayo Clinic.

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