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The FDA has approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which now has has approved indications for HER2-positive patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma.

Although hormone-targeting therapies have been a long-established strategy for the treatment of estrogen receptor (ER)-positive breast cancer, more than 20% of patients with early-stage disease relapse and those who progress to a metastatic stage eventually die from their illness.