FDA approvals November 30 - December 1, 2017

FDA approved Ogivri (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin (trastuzumab, Genentech, Inc.) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). More Information. December 1, 2017
FDA granted marketing approval to the FoundationOne CDx (F1CDx, Foundation Medicine, Inc.), a next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. More Information. November 30, 2017

Other Hematology/Oncology (Cancer) Approvals & Safety Notifications