FDA approves new drug for the treatment of HER2+ metastatic breast cancer

On June 8, the FDA approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2+ metastatic breast cancer. According to the FDA, the drug is intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy and is to be combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy. The FDA made its decision based on a single clinical trial involving 808 patients who were randomly assigned to receive Perjeta, trastuzumab, and docetaxel, or trastuzumab, docetaxel and a placebo. Those treated with the combination containing Perjeta had a median progression-free survival (PFS) of 18.5 months, compared to 12.4 months for those receiving the combination containing a placebo. For more information on the drug and the approval, read the FDA press release on Perjeta.


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