FDA Approves New Breast Cancer Drug From Genentech

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    NEWSLETTERS

    The Food and Drug Administration on Friday approved a new late-stage breast cancer drug developed by Genentech in South San Francisco. It combines the widely used breast cancer medicine Herceptin with a powerful toxin to more effectively kill cancer cells while potentially reducing side effects. Marianne Favro reports. (Published Friday, Feb 22, 2013)

    The Food and Drug Administration on Friday approved  a new late-stage breast cancer drug developed by  Genentech in South San Francisco.

    It combines  the widely used breast cancer medicine Herceptin with a powerful toxin to more effectively kill cancer cells while potentially reducing side effects.

    The drug, which will be called, Kadcyla, extended the median survival of women with advanced breast cancer by nearly half a year in a clinical trial. Some of the clinical trials were performed at a Walnut Creek Kaiser Hospital.

    “Kadcyla is an anti-body drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer . It helped people in the study live nearly six months longer” said Dr. Hal V. Barron, Genentech's chief medical officer and head of Global Product Development. Genentech is a member of the Roche Group.

    The drug  is approved for patients with HER2-positive breast cancer, about 20 percent of cases. 

    Kadcyla is expected to cost  about $9,800 a month, or $94,000 for a typical course of treatment. That is about twice the price of Herceptin itself, which is also made by Genentech. It compares in price to several other new cancer drugs.

    Kadcyla is one of the first successful examples of a new class of drug that links toxins to proteins known as monoclonal antibodies. The antibodies latch onto tumors and deliver the toxic payload. Because the toxin is not activated until it reaches the tumor, some side effects are avoided.

    Such medicines, known as antibody-drug conjugates, may also offer promise for treating other types of cancer.

    “We currently have more than 25 anti-body-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future,” Barron said.