Haythem Y. Ali, MD
Several biosimilars for trastuzumab (Herceptin) are under investigation, with one achieving an FDA approval at the close of 2017. The FDA approved MYL-1401O (Ogivri; trastuzumab-dkst) for use in HER2-positive breast cancer, as well as HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
Data from the phase III HERITAGE trial presented at the 2018 ASCO Annual Meeting showed that adding MYL-1401O (Ogivri; trastuzumab-dkst) to a taxane as initial therapy followed by MYL-1401O monotherapy as maintenance produced a nearly identical progression-free survival (PFS) rate at 48 weeks compared with trastuzumab (Herceptin) in patients with HER2-positive metastatic breast cancer.1
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