Tag Archives: Approves

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Print this page INCHEON, KOREA – January 21, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin®i (trastuzumab), across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma… Read More »

FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers

FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers Print this page November 26, 2018 — The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second time the agency has approved a cancer treatment… Read More »

FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan for Non-Hodgkin’s Lymphoma

FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan for Non-Hodgkin’s Lymphoma Print this page November 28, 2018 — The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or… Read More »