poliomyelitis treatment
poliomyelitis treatment Drug and Device News March 2019 - P&T Community Posted: 04 Mar 2019 10:35 AM PST NEW DRUG APPROVALS Ontruzant, a Herceptin Biosimilar The FDA has approved trastuzumabdttb (Ontruzant, Samsung Bioepis Company, Ltd.) for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Trastuzumabdttb, a HER2/neu receptor antagonist, is the third FDA-approved biosimilar of Herceptin (Genentech). Patients should be selected for therapy based on an FDA-approved companion diagnostic. Trastuzumab-dttb carries a boxed warning about the risks of cardiomyopathy, serious and fatal infusion reactions, embryo-fetal toxicity, and pulmonary toxicity. Ontruzant will be marketed and distributed in the U.S. by Merck. Sources: Samsung Bioepis, January 21, 2019; Ontruzant . prescribing information, January 2019; FDA, January 18, 2019 Vaxelis, a Combination Vaccine T...
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