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.

A phase 2 trial evaluated the safety and efficacy of quizartinib in patients with relapsed/refractory acute myeloid leukemia (AML), compared with salvage chemotherapy.

Acute myeloid leukemia can often appear suddenly in patients, without any detectable early symptoms. However, new research has identified the origins of AML, which can be detectable more than 5 years before the disease develops.

Only 34% of patients with chronic myeloid leukemia (CML) in a small study in China were likely to be positive about attempting treatment-free remission.