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The FDA has granted a priority review to a supplemental biologics license application for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer.

Although dual HER2 blockade strategies have become an important part of the treatment paradigm for patients with HER2-positive breast cancer, the complexities of administering these therapies continue to unfold.

The sequencing of therapies for patients with HER2-positive breast cancer is largely driven by stage of disease and hormone receptor status.

Sara M. Tolaney, MD, MPH, instructor of medicine, Harvard Medical School, attending physician of medical oncology, Dana-Farber Cancer Institute, discusses pertuzumab (Perjeta) in patients with HER2-positive breast cancer.

Sara M. Tolaney, MD, MPH, instructor of medicine, Harvard Medical School, attending physician of medical oncology, Dana-Farber Cancer Institute, discusses the current treatment landscape for patients with HER2-positive breast cancer.

Although drugs that target HER2 have transformed the prognosis for many patients with breast cancer, the development of resistant disease remains a significant clinical challenge.

Mark D. Pegram, MD, director of the Breast Cancer Oncology Program at Stanford Medicine, discusses challenges facing the treatment of patients with HER2-positive breast cancer.

Sara M. Tolaney, MD, MPH, instructor of medicine, Harvard Medical School, attending physician of medical oncology, Dana-Farber Cancer Institute, discusses neoadjuvant HER2-directed therapy for patients with breast cancer.

The FDA has extended its decision deadline by 3 months on a biologics license application for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. A final decision is expected on or before December 3, 2017.

The investigational HER2-targeting antibody-drug conjugate DS-8201 has received an FDA breakthrough therapy designation for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer.













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