Dr. Hurvitz on Importance of Biosimilars in HER2+ Breast Cancer

Sara A. Hurvitz, MD
Published: Friday, Dec 28, 2018



Sara A. Hurvitz, MD, director of the Breast Oncology Program, medical director of the Clinical Research Unit, University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses the importance of biosimilars in HER2-positive breast cancer.

Patient access to the HER2-targeted therapies trastuzumab (Herceptin) and pertuzumab (Perjeta) is extremely important because of their potential survival benefit. This class of drugs has altered the natural history of HER2-positive breast cancer, Hurvitz says. On a global scale, particularly in third-world countries, access to these agents can be limited. Biosimilars have to meet very stringent preclinical criteria for similarity to the reference product in terms of efficacy, toxicity, and other factors. Only then will the biosimilar be tested in a clinical trial. Hurvitz concludes that the biosimilars that have made it through clinical testing and earned regulatory approval should be widely accessible in order to drive down cost.

There are a number of trastuzumab biosimilars moving through the pipeline. Most recently, the FDA approved CT-P6 (Herzuma; trastuzumab-pkrb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer. CT-P6 is indicated for patients with adjuvant breast cancer of HER2 overexpressing node-positive or -negative breast cancer to be used as part of a treatment regimen comprised of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or as part of a regimen with docetaxel and carboplatin.
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Sara A. Hurvitz, MD, director of the Breast Oncology Program, medical director of the Clinical Research Unit, University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses the importance of biosimilars in HER2-positive breast cancer.

Patient access to the HER2-targeted therapies trastuzumab (Herceptin) and pertuzumab (Perjeta) is extremely important because of their potential survival benefit. This class of drugs has altered the natural history of HER2-positive breast cancer, Hurvitz says. On a global scale, particularly in third-world countries, access to these agents can be limited. Biosimilars have to meet very stringent preclinical criteria for similarity to the reference product in terms of efficacy, toxicity, and other factors. Only then will the biosimilar be tested in a clinical trial. Hurvitz concludes that the biosimilars that have made it through clinical testing and earned regulatory approval should be widely accessible in order to drive down cost.

There are a number of trastuzumab biosimilars moving through the pipeline. Most recently, the FDA approved CT-P6 (Herzuma; trastuzumab-pkrb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer. CT-P6 is indicated for patients with adjuvant breast cancer of HER2 overexpressing node-positive or -negative breast cancer to be used as part of a treatment regimen comprised of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or as part of a regimen with docetaxel and carboplatin.

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Addressing Uncertainties in Oncology BiosimilarsApr 30, 20201.5
Community Practice Connections™: Show Me the Data™: Leveraging the Evidence to Optimize Applications of Biosimilars in CancerAug 30, 20201.5
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