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Published on 12 June 2012

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New antibody breast cancer drug approved by FDA

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A new breast cancer treatment that acts in a similar way to trastuzumab has been approved by the US Food and Drug Administration (FDA).

Pertezumab, which is marketed by Roche as Perjeta, was successfully rushed through regulation as a priority review.

The humanised monoclonal antibody that, like trastuzumab, binds to the extracellular part of the human epidermal growth factor receptor (HER)-2, binds to a separate site.

The US regulatory body has approved pertezumab in combination with docetaxel chemotherapy plus trastuzumabfor use in treatment-naive patients with HER2-positive metastatic breast cancer.

Approval by the FDA is often considered a sign that European approval is likely to follow.

The FDA however has already requested data from upcoming yields of the medicine following the declaration by the manufacturer that production may be altered in time due to a “cell growth issue”.

Roche



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