title: Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor.
abstract: The recombinant human granulocyte colony-stimulating factor (G-CSF) known as filgrastim (Tevagrastim(®), Ratiograstim(®), Biograstim(®)) in Europe (approved in 2008) and tbo-filgrastim (Granix(®)) in the USA (approved in 2012; Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel) is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. This article presents pooled clinical data for tbo-filgrastim compared with Neupogen(®) (Amgen, Thousand Oaks, CA, USA) as well as tbo-filgrastim post-marketing safety data. The safety and efficacy of tbo-filgrastim were evaluated in three phase III studies in 677 patients receiving myelosuppressive chemotherapy and study drug (348 patients with breast cancer, 237 with lung cancer, 92 with non-Hodgkin lymphoma). In each study, the efficacy of tbo-filgrastim was similar to that of Neupogen. Overall, 633 (93.5 %) patients receiving the study drug experienced 6093 treatment-emergent adverse events (AEs), most of which were related to chemotherapy. Adverse events related to the study drug (tbo-filgrastim or Neupogen) were experienced by 185 (27.3 %) patients; 19 (2.8 %) had severe drug-related AEs, 5 (0.7 %) had drug-related serious AEs, and 6 (0.9 %) discontinued the study due to drug-related AEs. Overall, the most common drug-related AEs were bone pain (7.1 %), myalgia (4.0 %), and asthenia (4.4 %). The post-marketing safety profile of tbo-filgrastim was consistent with that observed during the clinical studies. The availability of tbo-filgrastim, a G-CSF with safety and efficacy comparable to those of Neupogen, provides physicians with an alternative treatment option for supportive care of patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.
authors.affiliation: Department of Haematology, St. George's Hospital, St. George's, University of London, Blackshaw Road, London, SW17 0RE, UK. rpetteng@sgul.ac.uk.
authors.forename: Ruth
authors.initials: R
authors.lastname: Pettengell
authors.affiliation: Teva ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bias
authors.affiliation: Teva ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany.
authors.forename: Udo
authors.initials: U
authors.lastname: Mueller
authors.affiliation: Teva ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany.
authors.forename: Nicole
authors.initials: N
authors.lastname: Lang
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000188:drug therapy*; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage / Q000009:adverse effects*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006401:Hematologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced* / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D006401:Hematologic Agents; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim
keywords: Adverse drug event; Drug toxicity; Filgrastim; Granulocyte colony-stimulating factor; Neutropenia; Safety