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Perjeta Approved for Certain Type of Early BC

Genentech news release; 2017 Dec 20

The FDA has approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy for adjuvant treatment for a certain type of early breast cancer.

Indications: Perjeta is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

Dosage and administration: Administer by intravenous infusion postoperatively every 3 weeks for a total of 1 year (up to 18 cycles).

Efficacy and safety: Approval is based on results of a phase 3 study showing that the combination significantly reduced the risk of invasive breast cancer recurrence or death by 18% vs trastuzumab and chemotherapy alone.

Side effects/risks: The most common adverse reactions are diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting.

Citation:

FDA Approves Genentech’s Perjeta (pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer [news release]. South San Francisco, CA: Genentech, Inc. December 20, 2017. https://www.businesswire.com/news/home/20171220006056/en/FDA-Approves-Ge.... Accessed December 31, 2017.

Perjeta [package insert]. South San Francisco, CA: Genentech, Inc., 2017. https://www.gene.com/download/pdf/perjeta_prescribing.pdf. Accessed December 31, 2017.