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Perjeta FDA Approval History

Last updated by Judith Stewart, BPharm on March 19, 2020.

FDA Approved: Yes (First approved June 8, 2012)
Brand name: Perjeta
Generic name: pertuzumab
Dosage form: Injection
Company: Genentech
Treatment for: Breast Cancer

Perjeta (pertuzumab) is a humanized monoclonal antibody indicated for the treatment of HER2-positive breast cancer.

Perjeta used in combination with Herceptin, another targeted therapy medicine, and Taxotere, a type of chemotherapy, to treat HER2-positive, metastatic breast cancer that hasn’t been treated with either Herceptin or chemotherapy yet. Perjeta was called Omnitarg in earlier studies.

Development timeline for Perjeta

Dec 20, 2017Approval FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer
Jun  5, 2017APHINITY Study Shows Genentech’s Perjeta-Based Regimen Reduced the Risk of Invasive Cancer Returning Compared to Herceptin and Chemotherapy in HER2-Positive Early Breast Cancer
Sep 30, 2013Approval FDA Approves Perjeta for Neoadjuvant Breast Cancer Treatment
Jun  8, 2012Approval FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
Feb  7, 2012FDA Grants Genentech's Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer

Further information

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