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Medinews
15 Dicembre 2017

FDA Approvals in GBM, Biosimilar in Breast Cancer and Gastric/GEJ Cancer, and Biomarker Assay

December 7, 2017 – The FDA has approved the trastuzumab biosimilar MYL-1401O7. The approved indications are for HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma, which are the same indications as trastuzumab. Genentech, the manufacturer of trastuzumab, holds an exclusive license for the metastatic gastric cancer indication, meaning that the drug cannot be marketed for that purpose until the … (leggi tutto)

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