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Pertuzumab is administered as an intravenous infusion in combination with trastuzumab and docetaxel as a first line treatment for HER2-positive metastatic breast cancer. [4] [3] It is also used in the same combination as a neoadjuvant (given to reduce the size of a tumor, prior to surgery or radiation) for HER2-positive early breast cancer; as of 2016 this use had not been shown to increase ...
FDA Advisory Committee Recommends Accelerated Approval of Genentech's Perjeta for Neoadjuvant Use in HER2-Positive Early Stage Breast Cancer The FDA Will Make a Final Decision by October 31 The ...
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Trastuzumab deruxtecan was approved for medical use in the United States in December 2019, [12] in Japan in March 2020, [14] in the European Union in January 2021, [8] [10] and in Australia in October 2021. [1] It is the first approved therapy by the US Food and Drug Administration (FDA) targeted to people with the HER2-low breast cancer ...
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Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. [13] Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions.
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Idecabtagene vicleucel was approved for medical use in the United States in March 2021. [4] [7] It is the first cell-based gene therapy approved by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma. [4] [7] It was approved for medical use in the European Union in August 2021. [5] [9]
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