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Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor

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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.

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Acknowledgments

This periodic safety update report was funded by Teva Branded Pharmaceutical Products R&D, Inc. The authors thank Anton Buchner and Reiner Elsaesser (both of Teva Ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany) for their support in providing the clinical data for this article and Gabriella Letinic-Klier, MD, Pharmacovigilance Expert, for the preparation of the periodic safety update report.

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Authors and Affiliations

  1. Department of Haematology, St. George’s Hospital, St. George’s, University of London, Blackshaw Road, London, SW17 0RE, UK

    Ruth Pettengell

  2. Teva ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany

    Peter Bias, Udo Mueller & Nicole Lang

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  1. Ruth Pettengell
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  2. Peter Bias
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Corresponding author

Correspondence to Ruth Pettengell.

Ethics declarations

The studies were approved by all local institutional review boards and conducted in accordance with the principles of the Declaration of Helsinki and the ethical principles of Good Clinical Practice guidelines. Written informed consent was obtained from all patients before the start of any study-related procedures.

Conflict of interest

Ruth Pettengell has received speaker honoraria from Teva and Takeda. Peter Bias, Udo Mueller, and Nicole Lang are employees of Teva Ratiopharm/Teva Pharmaceuticals, Inc. Peter Bias and Udo Mueller own stocks in Teva Ratiopharm/Teva Pharmaceuticals, Inc. Medical writing assistance was provided by Lisa Feder, PhD, of Peloton Advantage LLC and was funded by Teva Branded Pharmaceutical Products R&D, Inc. Teva provided a full review of the article.

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Pettengell, R., Bias, P., Mueller, U. et al. Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor. Support Care Cancer 24, 2677–2684 (2016). https://doi.org/10.1007/s00520-015-3057-2

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  • DOI: https://doi.org/10.1007/s00520-015-3057-2

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