Skip to content

    Breast Cancer Health Center

    Font Size
    A
    A
    A

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

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

    continued...

    "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.

    1 | 2

    Today on WebMD

    Breast Cancer Overview
    From mammograms to living after treatment.
    Dealing with breast cancer
    Get answers to your questions.
     
    woman having mammogram
    The 3 latest tips to know.
    woman undergoing breast cancer test
    Most abnormalities aren’t breast cancer.
     
    Resolved To Quit Smoking
    VIDEO
    Breast Cancer Treatments Improving
    Article
     
    Woman getting mammogram
    Article
    Screening Tests for Women
    Article
     
    serious woman
    Article
    Pink badge on woman chest to support breat cancer
    QUIZ
     
    what is your cancer risk
    Article
    breast cancer survivors
    Article