New G-CSF approved in Europe, in clinical trials in the U.S.

I am hearing there is a new G-CSF coming out on the market produced by Teva. What can you tell us about this product? —Lauren Covely, RN, BSN, OCN

In February 2014, Teva UK Limited announced the launch of lipegfilgrastim (Lonquex). Lipegfilgrastim is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF). Its active ingredient is a novel glyco-pegylated filgrastim molecule. Lipegfilgrastim is indicated for use in reducing the duration of neutropenia and decreasing the incidence of febrile neutropenia in adult patients who are treated with cytotoxic chemotherapy for maglignancy.

Lipegfilgrastim has undergone a full clinical development program as part of the assessment process for use in patients undergoing chemotherapy. The European Medicines Agency (EMA) recommended approval of lipegfilgrastim in July 2013. —Abimbola Farinde, PharmD, MS, BCPP, CGP, LCDC, PM/PRC, FASCP, FACA, FNAP, Rsci, ARSPharmS

SOURCE: Teva UK Limited launches Lonquex (lipegfilgrastim)—A new long-acting G-CSF [press release]. Castleford, England: Teva UK Ltd. http://finance.yahoo.com/news/teva-uk-limited-launches-lonquex-171600664.html. Accessed August 18, 2014.

A comparison study of lipegfilgrastim and pegfilgrastim is listed in ClinicalTrials.gov as currently recruiting participants (http://clinicaltrials.gov/show/NCT02044276). The primary objective of the study is to demonstrate noninferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy. —The Editors