Hematology

A second biosimilar to Amgen’s Neupogen, which treats neutropenia, has been approved in the United States. The FDA approved Pfizer’s filgrastim-aafi, which will be sold under the brand name Nivestym. Zarxio (filgrastim-sndz) was the first filgrastim biosimilar approved by the FDA in 2015.

The FDA approved the first targeted therapy for adults with relapsed or refractory acute myeloid leukemia with an IDH1 mutation. In addition, FDA also approved a companion diagnostic to be used to detect the specific mutations in the IDH1 gene.